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GSK Plays Defense After California Judge Approves Plaintiff’s Expert Testimony in High-Stakes Zantac Trial

Fierce Pharma reported:

After eluding thousands of federal lawsuits because a U.S. district judge rejected the science behind plaintiffs’ claims, GSK will be forced to defend itself against allegations that its fallen heartburn med Zantac causes cancer in state court this summer.

Late this week, California judge Evelio Grillo said he’d allow expert testimony to proceed after what’s known as a Sargon hearing, in which Evelio weighed the validity of claims on both sides of the argument.

The outcome differs from that in some 50,000 similar Zantac claims in federal court, which U.S. District Judge Robin Rosenburg tossed after ruling that plaintiffs’ experts leveraged “unreliable methodologies” to reach their conclusions.

Despite GSK’s arguments on a lack of “consistent or reliable evidence” linking its heartburn drug to cancer, a recent report in Bloomberg Businessweek suggested GSK’s own scientists had long known about the risks.

Cash-Rich BioNTech Plans to Spend About $1 Billion More on Research This Year

Reuters reported:

BioNTech plans to spend up to about 1 billion euros ($1.1 billion) more on research and development and buy back up to $500 million more of its shares this year, drawing on more than 21 billion euros from the now waning commercial success of its COVID-19 vaccine. In a statement on Monday, Germany’s BioNTech (22UAy.DE), Pfizer‘s (PFE.N) partner on the Comirnaty vaccine, said it plans to spend 2.4 to 2.6 billion euros on research and development (R&D) in 2023, up from 1.54 billion euros last year.

Thanks to its COVID-vaccine market lead in the Western world, BioNTech ended the year 2022 with a cash balance of 13.9 billion euros plus receivables, or cash it stands to receive, of 7.14 billion euros. Commercial revenues from the shot slipped 9% to 17.2 billion euros last year and are expected to drop further to about 5 billion euros in 2023, the company added.

Driving the increase in development costs, BioNTech has started testing four new infectious-disease vaccines on humans over the past few months, targeting influenza and COVID-19 in a combination shot and also herpes, malaria as well as shingles.

It will also continue with its traditional focus on oncology, seeking to use its mRNA technology to help the human immune system attack tumors.

Teen Overdose Deaths Have Doubled in Three Years. Blame Fentanyl.

The Hill reported:

Teen overdose deaths have doubled in three years, an alarming trend amid a historic decline in drug and alcohol use among high school students. The main reason is fentanyl. Teens consume the powerful opioid unwittingly, packaged in counterfeit pills tailored to resemble less potent prescription medications. Drug traffickers lace pills with fentanyl to boost the black-market high. Dangerously addictive, fentanyl can be lethal, especially to children experimenting with drugs.

Deaths from drug and alcohol rose from 788 in 2018 to 1755 in 2021 among children ages 15 to 19, according to data from the Centers for Disease Control and Prevention, tabulated by The Hill.

Many sources point to fentanyl as the leading cause of teen overdose death. Between 2010 and 2021, the number of adolescent deaths from black-market fentanyl and related synthetics rose more than twenty-fold, from 38 to 884, according to a 2022 study in the Journal of the American Medical Association.

Teens often buy counterfeit pills online, through social media channels. They might think they are getting Adderall, a prescription stimulant that treats ADHD, or Xanax, an anti-anxiety drug, or MDMA, a party drug variously known as ecstasy or molly.

Pfizer Signs Agreement With China on Improving Health Coverage in the Country

CNBC reported:

U.S. pharma giant Pfizer has signed an agreement with China to cooperate on improving the country’s health coverage, according to the company.

“We are aligned very much with the China ‘Healthy 2030’ [initiative] and we are trying to contribute as much as we can,” Pfizer CEO Albert Bourla told CNBC’s Eunice Yoon on Saturday. He declined to share further details, including dollar amounts.

China in 2016 announced a “Healthy China 2030” plan for improving the country’s public health services, medical industry and food and drug safety. The COVID-19 pandemic also highlighted shortfalls in China’s still-developing public health system.

The weekend comments did not discuss the Paxlovid drug for treating COVID. In January, Bourla said Pfizer had signed an agreement with a local partner to manufacture Paxlovid in China, which production could begin in as soon as three or four months.

Bayer Says Drug Research Focus No Longer on Women’s Health

Reuters reported:

Bayer (BAYGn.DE) said the focus of its drug research would shift away from women’s health, a traditional pillar of Germany’s largest drugmaker, to hone in on neurology, rare diseases and immunology.

The shifted focus comes as Bayer is due to have a change at the top in June. Incoming CEO Bill Anderson will have to deal with thousands of lawsuits claiming the Roundup weedkiller causes cancer, an underwhelming drug development pipeline and disgruntled investors looking for a strategic change.

A string of recent deals to become a major player in cell and gene therapy has resulted in a bigger role for neurology, rare diseases and immunology, said Stefan Oelrich, the head of Bayer’s pharmaceuticals unit.

FDA Exactech Implant Warning Urges Doctors to Monitor Patients for Failures, Need for Revision Surgery

AboutLawsuits.com reported:

Federal regulators are urging doctors to closely monitor patients with recalled Exactech joint replacements, due to the high risk of the devices failing and requiring revision surgery.

The U.S. Food and Drug Administration (FDA) issued an updated Exactech implant warning on March 23, providing recommendations for doctors and patients to watch for signs of hip or knee replacement failure. However, the agency indicates that individuals who are not yet experiencing trouble with the implants do not need to seek revision surgery to have the recalled components removed or replaced.

An Exactech implant recall was issued in February 2022, impacting more than 140,000 Optetrak, Optetrak Logic and Truliant knee replacement systems implanted in patients since 2004, as well as 1,500 similar components used in Exactech Vantage ankle replacements.

Since then, nearly 200 Exactech knee lawsuits and Exactech hip lawsuits have been filed and centralized before U.S. District Judge Nicholas G. Garaufis in the Eastern District of New York, since they each involve similar questions of fact and law about whether “out-of-specification” vacuum sealed bags caused a plastic tibial insert component to fail, leading to risky revision surgery.

U.S. FDA Proposes Higher Bar for Accelerated Approvals for Cancer Drugs

Reuters reported:

The U.S. health regulator on Friday proposed cancer drug developers in most cases conduct more rigorous trials to seek accelerated approval for their candidates.

The Food and Drug Administration‘s proposed recommendation follows criticism for the accelerated approval pathway, as well as an independent federal review into it after the controversial nod for Biogen Inc’s (BIIB.O) Alzheimer’s treatment Aduhelm.

Accelerated approvals allow the agency to move therapies that target serious and life-threatening conditions to the market more quickly but have been criticized because some drugs have later been proven to be ineffective.