GlaxoSmithKline PLC (GSK)

[idpickering]

In first Zantac trial, GSK and Boehringer Ingelheim gain key victory

In the first personal injury case that has gone to trial over Zantac, GSK and Boehringer Ingelheim have emerged with an important victory as a Chicago jury has rejected the claim of Angela Valadez that the heartburn drug caused her colon cancer.

Valadez, 89, who said she used the drug every day from 1995 to 2014, was seeking $640 million for her suffering. Earlier in the trial, a Cook County circuit judge denied her attempt to also collect punitive damages.

Valadez argued that GSK and Boehringer knew that Zantac’s main ingredient, ranitidine, could transform into a possible carcinogen called NMDA over time or when exposed to high temperatures and that the companies failed to warn customers.

https://www.fiercepharma.com/pharma/fir ... ey-victory

There might be a RNS issued by GSK at 0700hrs (UK) on this today?

Ian.

[idpickering]

Further to the above;

Statement: Zantac (ranitidine) litigation

· Jury in Valadez case in Illinois state court finds GSK not liable for plaintiff's colorectal cancer

· Verdict is consistent with scientific consensus that there is no consistent or reliable evidence that ranitidine increases the risk of any cancer

· GSK will continue to vigorously defend itself against all other claims

· Next Zantac trial (Williams) due to start in Illinois dismissed

GSK plc ( GSK) welcomes today's jury verdict in the Valadez case in Illinois state court finding in GSK's favour in the first Zantac case to go to trial. This outcome is consistent with the scientific consensus that there is no consistent or reliable evidence that ranitidine increases the risk of any cancer, supported by 16 epidemiological studies looking at human data regarding the use of ranitidine. GSK will continue to vigorously defend itself against all other claims.

https://www.investegate.co.uk/announcem ... n-/8219078

Ian.

[idpickering]

Statement: Zantac (ranitidine) litigation

GSK plc (LSE/NYSE: GSK) disagrees with the ruling by the Delaware State Court and will immediately seek an appeal. The decision by the State Court contradicts the Federal Court's MDL ruling under the same legal standard, which dismissed all cases alleging five cancer types, in December 2022.

Following the 16 epidemiological studies looking at human data regarding the use of ranitidine, the scientific consensus is that there is no consistent or reliable evidence that ranitidine increases the risk of any cancer.

The litigation in Delaware remains at an early stage, and the ruling, under the Daubert standard, relates only to the question of whether the methodology used by plaintiffs' experts is sufficiently reliable to allow them to present their evidence at trial.

The ruling does not mean that the Court agrees with plaintiffs' experts' scientific conclusions, and it does not determine liability.

GSK will continue to vigorously defend itself against all claims and manage this litigation in the best interests of shareholders. Alongside immediately seeking an appeal to the Delaware Supreme Court, the Company will file motions for dismissal pressing additional defenses, severance of cases, and proof-of-use by claimants; and, at the same time, the Company will progress to trials of individual cases.

https://www.investegate.co.uk/announcem ... n-/8237058

Ian (I hold GSK).

[idpickering]

ASCO positive Blenrep DREAMM-8 trial results

GSK plc (LSE/NYSE: GSK) today announced positive results from an interim analysis of the DREAMM-8 phase III head-to-head trial evaluating Blenrep (belantamab mafodotin), in combination with pomalidomide plus dexamethasone (PomDex), versus a standard of care, bortezomib plus PomDex, as a second line and later treatment for relapsed or refractory multiple myeloma. These late-breaking data, being presented today at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (31 May - 4 June) in Chicago, IL, were featured in the official ASCO press programme and simultaneously published in the New England Journal of Medicine.

https://www.investegate.co.uk/announcem ... s-/8237321

Ian.

[idpickering]

GSK are down 9. 5% as I type. I suppose that may be in connection with the Zantac issue I mentioned above?

RNS here; https://www.investegate.co.uk/announcem ... n-/8237058

No knee-jerk reactions from me on this. I shall continue to hold my GSK shares, thinking longer term than just today.

Ian.

[kempiejon]

I used ranitidine as an OTC indigestion aid.

Following the 16 epidemiological studies looking at human data regarding the use of ranitidine, the scientific consensus is that there is no consistent or reliable evidence that ranitidine increases the risk of any cancer.

So that's a relief and I miss it's low cost per tablet. Alternatives are much more expensive.

[monabri]

GSK are down 9. 5% as I type. I suppose that may be in connection with the Zantac issue I mentioned above?

RNS here; https://www.investegate.co.uk/announcem ... n-/8237058

No knee-jerk reactions from me on this. I shall continue to hold my GSK shares, thinking longer term than just today.

Ian.

I believe so (Zantac link).

[idpickering]

GSK are down 9. 5% as I type. I suppose that may be in connection with the Zantac issue I mentioned above?

RNS here; https://www.investegate.co.uk/announcem ... n-/8237058

No knee-jerk reactions from me on this. I shall continue to hold my GSK shares, thinking longer term than just today.

Ian.

I believe so (Zantac link).

Thanks for your input. I put the question mark in my above post deliberately. Besides Zantac, how can we know what else is lurking underneath?

Either way. I'm holding firm. I would buy more GSK today, but I'm a bit light in investable funds currently.

Ian.

[idpickering]

US FDA approves expanded age indication for GSK's Arexvy, the first respiratory syncytial virus (RSV) vaccine for adults aged 50-59 at increased risk

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Arexvy (Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted) for the prevention of RSV lower respiratory tract disease (LRTD) in adults 50 through 59 years of age who are at increased risk. In the US, the vaccine is currently approved for use in adults aged 60 and older and recommended by CDC/ACIP using shared clinical decision-making.

https://www.investegate.co.uk/announcem ... k-/8249658

Ian (I hold).

[idpickering]

nb This from yesterday evening;

Statement: Zantac (ranitidine) litigation - Kasza case

GSK plc (LSE/NYSE: GSK) welcomes the plaintiff's voluntary dismissal of the next Zantac case (Kasza), which was scheduled to start trial in Illinois state court on 10 June 2024. GSK did not settle Ms. Kasza's claim and has not paid anything in exchange for the voluntary dismissal.

Following the 16 epidemiological studies looking at human data regarding the use of ranitidine, the scientific consensus is that there is no consistent or reliable evidence that ranitidine increases the risk of any cancer.

GSK will continue to vigorously defend itself and manage this litigation in the best interests of the company and shareholders.

https://www.investegate.co.uk/announcem ... n-/8251922

Ian.

[idpickering]

Statement: Zantac (ranitidine) litigation - GSK starts process for appeal of recent Delaware Daubert decision

· Delaware Superior Court's ruling inconsistent with how Daubert standard* has previously been applied in Delaware and federal courts

· Application has been filed seeking right of appeal to the Delaware Supreme Court

· GSK, Pfizer, Sanofi, and Boehringer Ingelheim are all parties to the application

· Scientific consensus remains that there is no consistent or reliable evidence that ranitidine increases the risk of any cancer

GSK plc (LSE/NYSE: GSK) today confirms that the Company has taken the first step to seek appeal of the recent Daubert ruling, made by the Delaware Superior Court, which permits plaintiff expert testimony as part of the Zantac (ranitidine) litigation in Delaware. GSK strongly disagrees with the Delaware Superior Court's ruling and has filed an application with the court to appeal to the Delaware Supreme Court for interlocutory review of the decision. Pfizer, Sanofi, and Boehringer Ingelheim are all parties to the application.

https://www.investegate.co.uk/announcem ... n-/8252131

Ian (I hold).

[idpickering]

Omjjara approved in Japan for myelofibrosis.

GSK plc ( GSK) today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Omjjara (momelotinib) for the treatment of myelofibrosis. Omjjara is a once-a-day, oral JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor. The approval is based on data from the pivotal phase III MOMENTUM and SIMPLIFY-1 trials.

This is the fourth major regulatory approval for GSK's momelotinib in the treatment of myelofibrosis, following approval under the brand name Ojjaara from the US Food and Drug Administration and authorisations under the brand name Omjjara from the European Commission and the Medicines and Healthcare products Regulatory Agency in the UK.

https://www.investegate.co.uk/announcem ... s-/8273453

Ian.

[idpickering]

EMA validates Jemperli marketing authorisation,

GSK plc ( GSK) today announced the European Medicines Agency (EMA) has accepted its application to expand the use of Jemperli (dostarlimab) in combination with standard-of-care chemotherapy (carboplatin and paclitaxel) to all adult patients with primary advanced or recurrent endometrial cancer. The EMA's Committee for Medicinal Products for Human Use will begin the formal review process to make a recommendation to the European Commission, with approval expected in H1 2025.

https://www.investegate.co.uk/announcem ... on/8273137

Ian.

[idpickering]

GSK are down 4.66% as I type, and I had wondered why?

This from the Company News area of the GSK page on HL may shed some light as to the reason for the GSK share weakness today?

Shares in biopharma giant GSK tumbled on Thursday after a ruling by a US health agency narrowed usage recommendations for all respiratory syncytial virus (RSV) vaccines, restricting the addressable market for the company's Arexvy product.
Arexvy is currently approved by the Food and Drug Administration for the prevention of lung and lower airway infection caused by RSV in adults aged 60 and over.

However, the US Advisory Committee on Immunisation Practices (ACIP) of the Centers for Disease Control and Prevention said late on Wednesday that it was tightening its recommendations for adults in the 60-74 age category to those at risk of severe RSV, following feedback from the medical community. The ruling replaces the prior blanket "60+" years recommendation.

Meanwhile, a decision to extend the usage of RSV vaccines to those aged 50-59 was postponed pending more safety data.

https://www.hl.co.uk/shares/shares-sear ... -gbp0.3125

Ian.

[formoverfunction]

Thanks for that Ian, my stock scanner had been throwing up GSK all day. Just little time today to investigate why.

[monabri]

It's also due to the government (UK) deciding to go with Pfizer for their "RSV Jab**" rather than GSK's. So, this is the 2nd piece of adverse news this week. So, first it was the UK and then the US news.

**UK health authorities chose Abrysvo, the Pfizer (US:PFE) RSV vaccine, as its preferred formulation.

[GrahamPlatt]

It's also due to the government (UK) deciding to go with Pfizer for their "RSV Jab**" rather than GSK's. So, this is the 2nd piece of adverse news this week. So, first it was the UK and then the US news.

**UK health authorities chose Abrysvo, the Pfizer (US:PFE) RSV vaccine, as its preferred formulation.

As UK (HMG descision at the time) decided to go with a foreign supplier for the smallpox vaccine instead of choosing the superior version from the then-UK company Acambis. Just possibly because the owner of said foreign co. was a major Tory party donor. Possibly. Wonder what the reason is this time?

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