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In the pharmaceutical industry, GSK ranks as one of the largest firms by total sales. The company wields its might across several therapeutic classes, including respiratory, antiviral, and vaccines, and has been growing its presence in oncology and immunology, as well. GSK uses joint ventures to gain additional scale in certain markets like HIV.

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Un trabajador lechero en Nevada da positivo en gripe aviar H5N1. CDC investiga mientras la cepa se propaga en aves y ganado.

Gripe aviar en EE.UU.: trabajador lechero en Nevada da positivo

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El brote de H5N9, la separación de la OMS y las audiencias de Kennedy generan incertidumbre en salud pública y mercados.

Acciones de Moderna (MRNA) y Pfizer (PFE) reaccionan al brote de H5N9 y la separación de los CDC de la OMS

<a href="https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-approved-in-eu-for-treatment-of-relapsedrefractory-multiple-myeloma/" title="https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-approved-in-eu-for-treatment-of-relapsedrefractory-multiple-myeloma/">https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-approved-in-eu-for-treatment-of-relapsedrefractory-multiple-myeloma/</a>

Biotech

GSK Announces Blenrep Approved In The EU For Multiple Myeloma; Sixth Regulatory Approval For Blenrep Combinations With Applications Under Review In All Major Markets

The US Food and Drug Administration (FDA) on Wednesday extended the review period for the Biologics License Application (BLA) for GSK plc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) Blenrep combinations for relapsed or refractory multiple myeloma patients who have received at <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">least one prior line of therapy</a>.
<ul class="wp-block-list">
<li>GSK is consolidating in the middle of its 52-week range. <a href="https://www.benzinga.com/quote/GSK" target="_blank" rel="noreferrer noopener">See the chart here.</a></li>
</ul>
The <a href="https://otp.tools.investis.com/generic/regulatory-story.aspx?cid=410&amp;newsid=1969166" target="_blank" rel="noreferrer noopener">new</a> Prescription Drug User Fee Act (PDUFA) action date is Oct. 23, which allows the FDA to review additional information provided in support of the application.
The BLA is supported by efficacy results shown by Blenrep combinations in the pivotal DREAMM-7 and DREAMM-8 phase 3 trials in relapsed or refractory multiple myeloma.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/44873982/uk-becomes-first-country-to-authorize-blenrep-in-two-combo-regimens" rel="noreferrer noopener">UK Becomes First Country To Authorize Blenrep In Two Combo Regimens</a>
These include statistically significant and clinically meaningful progression-free survival results for Blenrep combinations versus triplet standard of care combinations in both trials and overall survival versus a daratumumab-based triplet in DREAMM-7.
The safety and tolerability profiles of the Blenrep combinations were broadly consistent with the known profiles of the individual agents.
GSK is confident in the data supporting Blenrep combinations and looks forward to ongoing constructive conversations with the FDA as they continue their review.
Blenrep combinations are currently approved in the UK, Japan, Canada, Switzerland (DREAMM-8 only at this time), and the United Arab Emirates. Applications are currently under review in all major markets globally, including the EU and China (based on the results of DREAMM-7, with Breakthrough Therapy Designation for the combination and priority review for the application).
Last week, the FDA&#8217;s Oncologic Drugs Advisory Committee (ODAC) voted against the overall benefit/risk profile at the proposed dosage of GSK&#8217;s <a target="_blank" href="https://www.benzinga.com/news/fda/25/07/46489262/gsks-blood-cancer-drug-faces-us-setback-due-to-fda-panels-eye-safety-warning" rel="noreferrer noopener">Blenrep combinations</a>.
Ahead of the meeting, the FDA staff <a href="https://www.fda.gov/media/187578/download" target="_blank" rel="noreferrer noopener">released</a> a document highlighting key issues, including high rates of ocular toxicity, such as keratopathy (changes in the corneal epithelium) and changes in visual acuity, as well as poor tolerability with each regimen, resulting in uncertainty regarding the appropriateness of the proposed dosages of belantamab mafodotin.
Despite differences in the belantamab mafodotin dosing regimens evaluated in DREAMM-7 and DREAMM-8, there were high rates of ocular toxicity in both trials.
GSK Price Action: GSK shares were down 0.04% at $38.01 at the time of publication on Thursday, <a href="https://www.benzinga.com/pro/" target="_blank" rel="noreferrer noopener">according to Benzinga Pro.</a>
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Photo by HJBC via Shutterstock

GSK's Blood Cancer Drug Review Extended As FDA Seeks More Data

WIIM

GSK shares are trading higher after the company announced an extension of the FDA review period for Blenrep in relapsed/refractory multiple myeloma, with a new PDUFA date set for October 23, 2025.

https://www.investegate.co.uk/announcement/rns/gsk--gsk/us-fda-review-extended-for-blenrep/8995592#:~:text=GSK%20plc%20(LSE%2FNYSE%3A,one%20prior%20line%20of%20therapy.

GSK Announces Extension Of U.S. FDA Review Period For Blenrep In Relapsed/Refractory Multiple Myeloma; New PDUFA Date Scheduled For October 23, 2025

The U.S. Food and Drug Administration&#8217;s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted against the overall benefit/risk profile at the proposed dosage of GSK plc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) Blenrep <a href="https://www.benzinga.com/general/biotech">(belantamab mafodotin-blmf) combinations</a>.
The belantamab mafodotin combinations were <a target="_blank" href="https://www.gsk.com/en-gb/media/press-releases/gsk-provides-update-on-us-fda-advisory-committee-review-of-blenrep-belantamab-mafodotin-blmf-combinations-for-patients-with-relapsedrefractory-multiple-myeloma/" rel="noreferrer noopener">evaluated</a> in adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.
The FDA will consider the committee&#8217;s recommendation as it finalises its review on Blenrep ahead of the 23 July 2025 PDUFA date.&nbsp;
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/44873982/uk-becomes-first-country-to-authorize-blenrep-in-two-combo-regimens" rel="noreferrer noopener">UK Becomes First Country To Authorize Blenrep In Two Combo Regimens</a>
Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable. There are approximately more than 180,000 new cases of multiple myeloma diagnosed globally each year.
GSK remains confident in the benefit/risk profile of Blenrep (belantamab mafodotin-blmf) and will continue to work closely with the FDA as they complete their review for Blenrep in patients with relapsed or refractory multiple myeloma.
Ahead of the meeting, the FDA staff <a target="_blank" href="https://www.fda.gov/media/187578/download" rel="noreferrer noopener">released</a> a document highlighting key issues of high rates of ocular toxicity, including keratopathy (changes in the corneal epithelium) and visual acuity changes, and poor tolerability seen with each regimen and the resulting uncertainty regarding the appropriateness of the proposed dosages of belantamab mafodotin.
Despite differences in the belantamab mafodotin dosing regimens evaluated in DREAMM-7 and DREAMM-8, there were high rates of ocular toxicity in both trials.
Most patients experienced Keratopathy and Visual Acuity (KVA) events, including high-grade events (all grades: 92% and 93% and Grade 3-4: 77% and 78%, in DREAMM-7 and DREAMM-8, respectively).
The majority of patients (70% in DREAMM-7 and 72% in DREAMM-8) experienced recurrent ocular toxicity events (median of 3 Grade 2 or higher KVA events).
Over 50% of patients (58% in DREAMM-7 and 57% in DREAMM-8) had ongoing Grade 2 or higher KVA events at the data cut-off.
In both trials, there were high rates of dose modifications due to KVA events and recurrent KVA events. The majority of patients (76% in DREAMM-7 and 78% in DREAMM-8) had at least one dose modification due to a KVA event.
The document noted that the corneal toxicity seen with belantamab mafodotin is a unique risk to this product and is not seen with currently available therapies for multiple myeloma.
In May, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) <a target="_blank" href="https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-receive-positive-chmp-opinion-in-relapsedrefractory-multiple-myeloma/" rel="noreferrer noopener">recommended</a> the approval of Blenrep for adults with relapsed or refractory multiple myeloma in combination with bortezomib plus dexamethasone (BVd) in patients who have received at least one prior therapy, and in combination with pomalidomide plus dexamethasone (BPd) in patients who have received at least one prior therapy including lenalidomide.
An approval decision by the European Commission is expected in the third quarter of 2025.
In 2022,&nbsp;GSK withdrew&nbsp;the U.S. marketing authorization for Blenrep following the FDA request, based on the previously announced outcome of the DREAMM-3 Phase 3 confirmatory trial,&nbsp;which did not meet the requirements of the FDA&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/11/41986367/gsk-raises-prospects-for-withdrawn-blood-cancer-drug-blenrep-to-return-to-us-market-heres-why" rel="noreferrer noopener">Accelerated Approval regulations</a>.&nbsp;
Price Action: At the last check Friday, GSK stock is trading lower by 1.86% to $35.79 during the premarket session.
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Photo by Tada Images via Shutterstock

Movers

GSK's Blood Cancer Drug Faces US Setback Due To FDA Panel's Eye Safety Warning

GSK is trading lower after an FDA advisory panel reportedly voted against its blood cancer drug Blenrep in combination with bortezomib and dexamethasone for previously treated patients.

FDA Advisory Panel Votes Against GSK Blood Cancer Drug Blenrep In Combination With Bortezomib And Dexamethasone In Previously Treated Patients

<ul>
<li>Prefilled syringe presentation offers a convenient administration option to healthcare professionals</li>
<li>An estimated one million people develop shingles in the US each year1</li>
</ul>
GSK plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) today announced that the US Food and Drug Administration (FDA) has approved a prefilled syringe presentation of SHINGRIX(Zoster Vaccine Recombinant, Adjuvanted) for the prevention of shingles (herpes zoster). The new prefilled syringe removes the need to reconstitute separate vials prior to administration, simplifying the vaccine administration process for healthcare professionals.
The existing vaccine presentation consists of two vials, a lyophilized (powder) antigen and a liquid adjuvant, which healthcare professionals combine prior to administering. The approval of the new presentation is based on data demonstrating technical comparability between the new and existing vaccine presentation.

FDA Approves GSK's Prefilled Syringe Presentation Of SHINGRIX For Prevention Of Shingles

On Monday, the U.S. Food and Drug Administration (FDA) agreed to review GSK plc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) application to extend the indication of Arexvy (Respiratory Syncytial Virus Vaccine, Adjuvanted) to adults aged 18-49 <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">who are at increased risk</a>.
GSK's RSV vaccine is approved in the U.S. to prevent lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 and older, as well as those aged 50-59 years at increased risk for LRTD caused by RSV.
RSV, a common contagious virus affecting the lungs and breathing passages, impacts an estimated 64 million people of all ages globally every year. More than 125 million adults in the U.S. are under 50. An estimated 21 million of these people have at least one diagnosed risk factor for severe RSV infection, such as chronic obstructive pulmonary disease, asthma, congestive heart failure, and coronary heart disease.
The regulatory submission is <a href="https://us.gsk.com/en-us/media/press-releases/fda-accepts-application-to-review-expanded-use-of-gsk-s-rsv-vaccine-arexvy/" target="_blank" rel="noreferrer noopener">supported</a> by a Phase 3b trial evaluating immune response and safety in adults aged 18-49 who are at increased risk compared to adults aged 60 and above.
The safety and reactogenicity data were consistent with those from the Phase 3 program, which supported the vaccine&#8217;s initial approval in the U.S.
A regulatory decision by the FDA on this submission is expected in the first half of 2026.
In June, the FDA expanded approval of Moderna Inc.'s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) respiratory syncytial virus vaccine to adults aged 18-59 at increased risk <a href="https://www.benzinga.com/news/health-care/25/06/45921359/fda-expands-modernas-rsv-vaccine-use-to-at-risk-adults-aged-18-59-amid-cdc-panel-shake-up" target="_blank" rel="noreferrer noopener">for disease</a>. That same month, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend Merck &amp; Co Inc's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>) Enflonsia (clesrovimab-cfor) as an option for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in infants younger than 8 months of age who are born during or entering their first RSV season.
With a <a target="_blank" href="https://www.cdc.gov/media/releases/2025/2025-cdcs-advisory-committee-on-immunization-concludes-meeting-with-joint-statement.html" rel="noreferrer noopener">five-to-two </a>majority, RFK Jr.'s newly constituted committee made its first ruling. This body was formed after RFK Jr. entirely replaced the previous 17-member panel <a target="_blank" href="https://www.benzinga.com/news/health-care/25/06/46136734/rfk-jrs-cdc-panel-recommends-mercks-rsv-shot-for-infants" rel="noreferrer noopener">with his selections</a>.
Also, in June, Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) announced that it will begin shipping Beyfortus (nirsevimab) in early Q3 to ensure broad availability well ahead of the 2025-2026 respiratory syncytial virus (RSV) season, which typically starts in November and <a href="https://www.benzinga.com/news/health-care/25/06/45839621/beyfortus-output-tripled-as-sanofi-astrazeneca-scale-up-for-rsv-season" target="_blank" rel="noreferrer noopener">runs through March</a>.
In collaboration with its partner AstraZeneca plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>), Sanofi has tripled production capacity and doubled the number of manufacturing sites since the launch of Beyfortus in 2023.
Last week, GSK announced it has started shipping doses of its trivalent seasonal influenza vaccines to U.S. healthcare providers and pharmacies in preparation for the 2025-26 flu season.
This immediately follows FDA licensing and approval of the lot release. FLULAVAL and FLUARIX will be available in a 0.5mL, single-dose, pre-filled syringe and are indicated for people <a href="https://www.benzinga.com/pressreleases/25/07/b46342250/gsk-begins-shipping-influenza-vaccine-doses-for-the-2025-26-flu-season" target="_blank" rel="noreferrer noopener">six months and older</a>.
Price Action: GSK stock is down 1.36% at $37.77 at the last check on Tuesday.
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Photo: Shutterstock

GSK Seeks FDA Nod To Broaden RSV Vaccine For Younger At-Risk Adults

Bristol-Myers Squibb &amp; Co. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) is gearing up to announce its <a target="_blank" href="https://www.benzinga.com/pressreleases/25/06/b45900314/bristol-myers-squibb-to-report-results-for-second-quarter-2025-on-july-31-2025" rel="noreferrer noopener">second-quarter 2025</a> earnings on July 31, with expectations for adjusted earnings of $1.585 per share on sales of $11.31 billion, according to data from <a target="_blank" href="https://www.benzinga.com/pro/feature/newsfeed" rel="noreferrer noopener">Benzinga Pro</a>.
While revenue and underlying earnings per share estimates for the current quarter and full-year 2025 have seen slight downward revisions, the U.S. pharma giant anticipates a low-single-digit percentage increase in total revenue for the later 2020s, primarily driven by updated assumptions for its cancer drug Yervoy.
The upcoming earnings call is expected to shed light on the performance of key products, future milestones, and the impact of U.S. drug pricing policies on the broader industry.
Read Next: <a target="_blank" href="https://www.benzinga.com/news/legal/25/06/46098969/bristol-myers-faces-scrutiny-for-allegedly-rigging-market-on-2b-cancer-drug" rel="noreferrer noopener">Bristol Myers Faces Scrutiny For Allegedly Rigging Market On $2 Billion Cancer Drug</a>
Bank of America Securities (BofA) updated the company&#8217;s earnings model. For the second quarter, BofA&#8217;s total revenue estimates and EPS decline by more than 1%, with no significant changes; for 2025, there are no major changes, revenue and underlying earnings per share decrease by more than 1%.
For the later 2020s, total revenue estimates increase by a low-single-digit percentage, primarily related to updated loss-of-exclusivity assumptions for Yervoy. BofA maintains a Neutral rating <a target="_blank" href="https://www.benzinga.com/quote/BMY/analyst-ratings" rel="noreferrer noopener">and a price forecast of $56</a>, using an 8x P/E multiple on updated 2025E EPS.
Analyst Tim Anderson notes that while Bristol-Myers Squibb has described the Inflation Reduction Act&#8217;s (IRA) Medicare Part D reform as &#8220;potentially net neutral across the portfolio,&#8221; certain products like Pomalyst, Revlimid, Camzyos, and Orencia (subcutaneous) are expected to have greater headwinds.
As the upcoming earnings call approaches, investors and analysts will be keenly focused on a few critical areas that will shape Bristol Myers Squibb&#8217;s narrative.
A significant portion of the discussion is anticipated to revolve around the evolving landscape of U.S. drug pricing policies. The specter of initiatives like the &#8216;most favored nation&#8217; rule, alongside the potential imposition of pharma-specific tariffs under Section 232, casts a long shadow over the entire pharmaceutical industry, and Bristol Myers Squibb is certainly not immune to these systemic pressures.
Beyond these broader industry concerns, the call will undoubtedly provide crucial updates on the commercial performance and future potential of key products within the company&#8217;s portfolio, including Cobenfy, Camzyos, Reblozyl, and Breyanzi.
Their trajectory in the market will be a strong indicator of the company&#8217;s immediate revenue streams. Additionally, stakeholders will be eager to hear about upcoming milestones slated for 2025, which could provide insights into future product launches, regulatory decisions, or significant clinical trial readouts.
While the company navigates these operational and policy challenges, its valuation remains a talking point among analysts. As analyst Anderson points out, Bristol Myers Squibb &#8220;remains one of the cheaper companies in large-cap biopharma,&#8221; but it&#8217;s no longer unusually cheap. Its price-to-earnings ratio of 7 to 8 times expected 2025 earnings is now similar to peers like Pfizer Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>), GSK Plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>), Biogen Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>), and Merck &amp; Co. Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>).
Despite this current valuation, the road ahead appears challenging. The company is bracing for several tough years, with an anticipated decline in earnings primarily driven by the relentless pressure from generic competition.
This looming threat to its established revenue streams means that achieving meaningful medium-term growth will be a significant hurdle for Bristol Myers Squibb to overcome.
Price Action: BMY stock is trading higher by 1.52% to $47.57 at last check Monday.
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</ul>
Photo via Shutterstock

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BIIB

Is Bristol-Myers Squibb Still An Undervalued Biopharma Play?

<ul>
<li>&nbsp;Multiple real-world studies show consistent high effectiveness of Vocabria + Rekambys (cabotegravir + rilpivirine LA (CAB+RPV LA)) across a broad range of populations</li>
<li>Implementation science data for Apretude (cabotegravir long-acting (CAB LA) for PrEP) demonstrate 95% of participants were happy they switched from oral PrEP to CAB LA</li>
</ul>
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced data from the phase IIIb VOLITION study demonstrating that 89% (n=129/145) of eligible treatment-naïve people living with HIV opted to switch to long-acting injectable Vocabria + Rekambys (branded as Cabenuva in the US Canada and Australia) following rapid viral suppression with daily Dovato (dolutegravir/lamivudine (DTG/3TC)). Additional real-world data from other studies reinforce CAB+RPV LA's effectiveness across a broad range of populations.

ViiV Reports Real-World Data For Long-Acting HIV Regimens: 89% Of Treatment-Naïve Patients Opt For Vocabria + Rekambys After Rapid Suppression; 95% Prefer Apretude Over Oral PrEP

<ul>
<li>Agreement allows manufacturers to develop, manufacture and supply generic long-acting injectable cabotegravir (CAB LA) for treatment in 133 countries</li>
<li>Builds on the voluntary licence for CAB LA for HIV pre-exposure prophylaxis (PrEP), enabling increased access to innovative long-acting injectables for HIV treatment</li>
</ul>
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced an update to their voluntary licensing agreement with the Medicines Patent Pool (MPP) for cabotegravir to include patents relating to its use in a long-acting HIV treatment regimen. The announcement follows updated guidance from WHO recommending long-acting injectable cabotegravir + rilpivirine as an HIV treatment option.
Existing generic licensees for prevention will be able to develop, manufacture and supply generic CAB LA, for use in combination with long-acting rilpivirine, subject to required regulatory approvals being obtained, to help enable access to the long-acting treatment in 133 countries worldwide. This includes all least-developed, low-income, lower middle-income and Sub-Saharan African countries, as well as countries where ViiV does not have patent rights for cabotegravir.

Global

ViiV Expands Licensing Deal With Medicines Patent Pool To Allow Generic Production Of Long-Acting Injectable HIV Treatment Cabotegravir + Rilpivirine In 133 Countries

GILD

Shares of drug stocks are trading lower after the FDA reportedly indicated it could fast track drugs to companies that cut US prices in line with other countries.

The Delaware Supreme Court has overturned a lower court&#8217;s decision that allowed expert testimony supporting plaintiffs&#8217; claims in a high-profile case alleging that Zantac, or its generic ranitidine, <a target="_blank" href="https://www.benzinga.com/general/biotech/24/05/38946928/gsk-concealed-risk-associated-with-discontinued-heart-burn-drug-zantac-whistleblower-lawsuit-clai" rel="noreferrer noopener">can cause cancer</a>.
The justices concluded that the trial court applied an incorrect legal standard when it ruled that the reliability of expert opinions should be determined by a jury rather than by the judge.
Initially marketed by a forerunner of&nbsp;GSK plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>), Zantac, once a blockbuster heartburn drug, has been sold at different times by companies, including&nbsp;Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>), Boehringer Ingelheim, Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>), and <a target="_blank" href="https://www.benzinga.com/general/biotech/23/06/32917283/sanofi-stock-is-trading-higher-today-heres-why" rel="noreferrer noopener">several generic drugmakers</a>.
Also Read: <a target="_blank" href="https://www.benzinga.com/news/politics/25/07/46258994/trumps-big-beautiful-bill-hands-5-billion-win-to-big-pharma-report" rel="noreferrer noopener">Trump&#8217;s &#8216;Big, Beautiful Bill&#8217; Hands $5 Billion Win To Big Pharma: Report</a>
The case centers on nearly 75,000 plaintiffs who claim their cancer diagnoses were caused by exposure to ranitidine, the active ingredient in Zantac, which may degrade into the probable human carcinogen NDMA.
Plaintiffs submitted expert reports linking the drug to ten types of cancer, but the defendants challenged the validity of those reports, questioning the scientific methods used.
The Superior Court <a target="_blank" href="https://courts.delaware.gov/Opinions/Download.aspx?id=382080" rel="noreferrer noopener">denied</a> motions to exclude the expert opinions, citing Delaware&#8217;s &#8220;liberal thrust&#8221; toward admitting expert testimony. It found that any methodological disputes were issues for the jury.
The court also allowed the experts to base their causation claims on studies involving NDMA, rather than requiring a direct link to Zantac itself.
However, the Supreme Court found this reasoning flawed. In its opinion, the court emphasized that Delaware&#8217;s rules on expert evidence align with federal standards, which burden the proponent to prove that testimony is based on sufficient and reliable scientific methods.
The court also faulted the trial judge for improperly framing the central question of general causation. Rather than asking whether Zantac specifically could cause cancer, the lower court allowed experts to rely on data involving NDMA without demonstrating that Zantac exposure levels were comparable to those in the referenced studies.
The Supreme Court ruled that this failed to establish a scientifically valid connection between the product and the alleged harm.
In June, a federal judge ruled that key claims brought by plaintiffs against Patheon Manufacturing Services in the Zantac litigation may move forward, while one claim related to <a href="https://www.benzinga.com/general/biotech/22/12/29989120/relief-to-pfizer-sanofi-as-us-dismisses-several-lawsuits-associated-with-zantac" target="_blank" rel="noreferrer noopener">misrepresentation was dismissed</a>.
In its motion to dismiss, Patheon argued that the plaintiffs&#8217; claims failed on multiple fronts. The company said the plaintiffs did not identify a specific manufacturing defect, asserted that the design defect claim was preempted by federal law, and claimed that negligence was not pled with adequate specificity.
Additionally, Patheon <a href="https://business.cch.com/plsd/InreZantac6-16-25.pdf" target="_blank" rel="noreferrer noopener">contended</a> that no valid misrepresentation claim had been made. However, the court found that plaintiffs had adequately stated distinct claims for manufacturing and design defects.
The judge noted that plaintiffs alleged a flawed manufacturing process that caused ranitidine to form NDMA, a probable carcinogen, or that the manufacturing method contributed to the contamination. The court ruled that, at this stage of litigation, those allegations were sufficient to proceed.
On the negligence claim, the judge concluded that plaintiffs had met the specificity requirements under Rule 9(b), citing detailed allegations that Patheon exposed ranitidine to heat and humidity, leading to its degradation into NDMA.
The court emphasized that the claims were grounded in either violations of federal law or state law duties not solely governed by the FDA, meaning federal preemption did not apply at this stage.
Although the court, in June, agreed with Patheon that the plaintiffs had not asserted a misrepresentation claim, it allowed the remaining claims to proceed.
In May 2024, Pfizer settled 10,000 lawsuits alleging it concealed the cancer risks associated with its Zantac heartburn medication, marking the <a target="_blank" href="https://www.benzinga.com/general/biotech/24/05/38710835/pfizer-agrees-to-settle-over-10-000-lawsuits-about-cancer-risks-associated-with-discontinued-hear" rel="noreferrer noopener">largest resolution in the litigation</a>.&nbsp;
In October 2024, GSK reached agreements with ten plaintiff firms representing approximately 80,000 Zantac product liability&nbsp;cases in the <a target="_blank" href="https://www.benzinga.com/general/biotech/24/10/41295498/gsk-settles-majority-of-zantac-lawsuits-but-pipeline-doubts-remain" rel="noreferrer noopener">U.S. state courts</a>.
Price Action: PFE stock is down 0.43% at $25.67, and SNY stock is down 1.01% at $48.84 during the premarket session at last check Friday.
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Image via Shutterstock

Legal

Pfizer, Sanofi Find Relief As Delaware Top Court Rejects Zantac Expert Testimony

<a href="https://www.bloomberg.com/news/articles/2025-07-10/delaware-court-sides-with-zantac-makers-in-cancer-claims-suits" title="https://www.bloomberg.com/news/articles/2025-07-10/delaware-court-sides-with-zantac-makers-in-cancer-claims-suits">https://www.bloomberg.com/news/articles/2025-07-10/delaware-court-sides-with-zantac-makers-in-cancer-claims-suits</a>

'Delaware Court Sides With Zantac Makers In Cancer Claims' - Bloomberg News

<ul>
<li>&nbsp;GSK supports seasonal flu immunization in the US by shipping FLULAVAL (Influenza Vaccine) and FLUARIX (Influenza Vaccine) in advance of flu season</li>
</ul>
GSK plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) today announced it has started shipping doses of its trivalent seasonal influenza vaccines to US healthcare providers and pharmacies in preparation for the 2025-26 flu season. This immediately follows a licensing and lot-release approval from the US Food and Drug Administration (FDA). Both FLULAVAL and FLUARIX will be available in a 0.5mL, single-dose, pre-filled syringe and are indicated for people six months and older.
According to the US Centers for Disease Control and Prevention (CDC), annual influenza vaccination is the first and most important action recommended to reduce the risk of flu and its potentially serious outcomes. Ideally, vaccination should occur by the end of October, but people can continue to get vaccinated as long as the flu poses a threat.1 CDC recommends an annual flu vaccination for anyone aged six months or older who does not have contraindications.1,2
CDC estimates that from October 1, 2024, through May 17, 2025, there were 47 – 82 million flu illnesses, 610,000 – 1.3 million flu hospitalizations and 27,000 – 130,000 flu deaths.3 The 2024-25 flu season was the first season since 2017-18 that the CDC classified as high severity, and preliminary CDC estimates indicate that it was the worst flu season (based on flu illnesses, hospitalizations and deaths) the US has seen in the last 15 years.4,5
For egg-based influenza vaccines for the 2025-26 flu season in the Northern Hemisphere, the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended including an A/Victoria/4897/2022 (H1N1)pdm09-like virus, an A/Croatia/10136RV/2023 (H3N2)-like virus and a B/Austria/1359417/2021 (B/Victoria lineage)-like virus.6

GSK Begins Shipping FLULAVAL And FLUARIX Vaccines In U.S. Ahead Of 2025–26 Flu Season Following FDA Approval

<ul>
<li>Real-world and implementation data describe effectiveness of long-acting Vocabria + Rekambys (cabotegravir + rilpivirine LA (CAB+RPV LA)) for HIV treatment and assess experiences of using Apretude (cabotegravir long-acting (CAB LA) for PrEP)in range of populations</li>
<li>New phase IIIb data look at preferences among treatment-naive adults offered the choice to switch to CAB+RPV LA after attaining rapid viral suppression with Dovato (DTG/3TC) daily oral therapy</li>
<li>Interim data from wave three of the Positive Perspectives study demonstrate impact of joint decision-making on HIV treatment satisfaction and health outcomes</li>
</ul>
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced the presentation of abstracts from its innovative HIV treatment and prevention portfolio at the International AIDS Society 2025 Conference (IAS 2025) in Kigali, Rwanda. Key data will highlight the long-term effectiveness of Vocabria &amp; Rekambys, (branded as Cabenuva in the US, Canada and Australia) the company's complete long-acting injectable regimen for treatment; evaluate patient preference for long-acting injectables compared to daily oral therapy; and measure benefits of long-acting injectables in tackling common challenges associated with taking daily pills, including stigma and adherence.

ViiV Healthcare Showcases Data At IAS 2025 Highlighting Long-Term Effectiveness And Patient Preference For Long-Acting HIV Injectables Vocabria + Rekambys And Apretude Over Daily Oral Therapy

<a href="https://www.gov.uk/drug-safety-update/abrysvov-pfizer-rsv-vaccine-and-arexvyv-gsk-rsv-vaccine-be-alert-to-a-small-risk-of-guillain-barre-syndrome-following-vaccination-in-older-adults" title="https://www.gov.uk/drug-safety-update/abrysvov-pfizer-rsv-vaccine-and-arexvyv-gsk-rsv-vaccine-be-alert-to-a-small-risk-of-guillain-barre-syndrome-following-vaccination-in-older-adults">https://www.gov.uk/drug-safety-update/abrysvov-pfizer-rsv-vaccine-and-arexvyv-gsk-rsv-vaccine-be-alert-to-a-small-risk-of-guillain-barre-syndrome-following-vaccination-in-older-adults</a>

UK's MHRA Says There Is Small Increase In Risk Of Guillain-Barré Syndrome Post Vaccination With Abrysvo And Arexvy In Adults Aged 60 Years & Older; Commission On Human Medicines Advise That Benefits Of Vaccination Against RSV Outweigh Small Risk Of Developing Guillain-Barré Syndrome; Currently No Evidence Of Increased Risk Of Guillain-Barré Syndrome In Pregnant Women Following Vaccination With Abrysvo

The House Judiciary Committee has subpoenaed Dr. Philip Dormitzer, a former Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) executive, in connection with an investigation into claims that the company intentionally delayed the release of <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">clinical testing results</a> for its COVID-19 vaccine until after the 2020 presidential election.
The move signals an escalation in the panel's probe into whether political considerations influenced Pfizer's vaccine announcement timeline.
Dormitzer, who later joined British drugmaker GSK Plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>), is considered a key witness in the inquiry.
Also Read: <a target="_blank" href="https://www.benzinga.com/news/health-care/25/06/46123159/pfizer-seeks-label-expansion-for-hemophilia-drug-after-promising-data" rel="noreferrer noopener">Pfizer Seeks Label Expansion For Hemophilia Drug After Promising Data</a>
Benzinga reached out to Pfizer for comment.
According to the committee, he has not voluntarily complied with previous requests to appear or provide documents.
The subpoena, first reported by CNN, reflects lawmakers&#8217; belief that Dormitzer&#8217;s testimony is central to understanding internal decision-making at Pfizer during the development of the vaccine.
The committee points to allegations that Dormitzer, after joining GSK, told colleagues that Pfizer had deliberately delayed disclosing the vaccine&#8217;s effectiveness until after Election Day.
The CNN <a target="_blank" href="https://edition.cnn.com/2025/06/30/politics/pfizer-covid-vaccine-philip-dormitzer" rel="noreferrer noopener">report </a>added that the Wall Street Journal previously reported that GSK had flagged those statements to federal prosecutors in New York.
According to House Judiciary Chair Jim Jordan, GSK provided information from a human resources meeting in November 2024 in which Dormitzer allegedly expressed concern about being investigated by a future Trump administration, suggesting the vaccine announcement timing was "not a coincidence."
Further, Jordan's letter cites claims that Dormitzer informed colleagues that Pfizer&#8217;s top R&amp;D leadership intentionally slowed clinical testing so that it would not conclude before the election results were known. The Judiciary Committee has received some records from GSK but has not made them public.
Pfizer announced the COVID-19 vaccine's effectiveness on Nov. 9, 2020, six days after Election Day.
CEO Albert Bourla has previously denied political motives, telling CNN that the timing was based solely on data readiness and regulatory review, not election considerations.
While the committee has not issued a subpoena to Pfizer, it seeks information directly from the company as the investigation progresses.
Price Action: PFE stock is currently 0.80% higher at $25.24, as of the last check on Wednesday.
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Photo: Shutterstock

Lawmakers Investigate Whether Pfizer Delayed COVID-19 Vaccine Results For Political Reasons

In the current session, GSK Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) is trading at $38.51, after a 1.13% drop. Over the past month, the stock fell by 5.54%, and in the past year, by 0.77%. With performance like this, long-term shareholders are more likely to start looking into the company's price-to-earnings ratio. 

<img src="https://www.benzinga.com/files/images/story/2025/1751475959_0.png" alt="Past Year Chart" />

<h3>How Does GSK P/E Compare to Other Companies?</h3>
The P/E ratio is used by long-term shareholders to assess the company's market performance against aggregate market data, historical earnings, and the industry at large. A lower P/E could indicate that shareholders do not expect the stock to perform better in the future or it could mean that the company is undervalued. 
GSK has a lower P/E than the aggregate P/E of 27.89 of the Pharmaceuticals industry. Ideally, one might believe that the stock might perform worse than its peers, but it's also probable that the stock is undervalued. 

<img src="https://www.benzinga.com/files/images/story/2025/1751475959_1.png" alt="Guage" />

In conclusion, the price-to-earnings ratio is a useful metric for analyzing a company's market performance, but it has its limitations. While a lower P/E can indicate that a company is undervalued, it can also suggest that shareholders do not expect future growth. Additionally, the P/E ratio should not be used in isolation, as other factors such as industry trends and business cycles can also impact a company's stock price. Therefore, investors should use the P/E ratio in conjunction with other financial metrics and qualitative analysis to make informed investment decisions.

Intraday Update

Price Over Earnings Overview: GSK

Press Releases

Spero Therapeutics and GSK Announce PIVOT-PO Phase 3 Study for Tebipenem HBr Stopped Early for Efficacy Following Review by Independent Data Monitoring Committee

Small-Cap Movers Under $1: HIT, SPRO, SGN, PRSO, SGBX Drive Momentum Across AI, Biotech, Crypto, Software, Etc.

Theravance Biopharma, Inc. Sells Remaining Royalty Interest in Trelegy Ellipta to GSK for $225 Million

GSK announces the Linked by Lupus: Optimal Care Initiative to help support individuals with lupus in the US

FDA approves Benlysta (belimumab) Autoinjector for children with active lupus nephritis

GSK begins shipping influenza vaccine doses for the 2025-26 flu season

US FDA Approves GSK's SHINGRIX in a Prefilled Syringe Presentation

INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of GSK plc – GSK

GSK sponsors 2025 National Senior Games as part of Sideline RSV campaign to raise awareness of RSV in older adults

INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of GSK plc - GSK

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