Is AstraZeneca exploring a massive merger with BMS?

AstraZeneca is in talks to combine with Bristol Myers Squibb in a potential deal that would create a nearly $400 billion pharmaceutical giant, the Financial Times reports. If it happens, the merger would be one of the largest in biopharma history. Discussions have taken place in recent months but could still fall apart, people familiar with the matter told FT.

The merger would significantly expand U.K.-based AstraZeneca’s footprint in the U.S. and bolster its oncology business. It could also potentially help BMS navigate looming patent expirations, though any transaction would likely face intense antitrust and political scrutiny on both sides of the Atlantic.

AZ shares were down about 5% in London trading Monday, while Bristol shares were up 5% in premarket trading in the U.S.

vaccines

Moderna is set for a pivotal FDA flu vaccine decision

The FDA will likely decide this week whether or not to approve Moderna’s experimental mRNA influenza vaccine — potentially the first licensed flu shot based on mRNA technology.

This has been a closely watched regulatory journey: In February, Vinay Prasad, the head of CBER at the time, overturned the recommendation of career staff to issue a rare “refusal-to-file” notice to the company, saying it wouldn’t even review the vaccine based on its clinical trial design and the data Moderna had submitted. Prasad, of course, has since left the FDA, and an independent advisory committee voted unanimously in June that the vaccine’s benefits outweigh its risks.

Although there are plenty of flu vaccines on the market, pandemic preparedness experts believe the manufacturing speed made possible by nRNA vaccines could be very useful if the need for a pandemic flu shot were to arise.

drug pricing

Contested 340B rebate pilot program is revised

The Trump administration is revising a controversial pilot that would let some drugmakers replace 340B discounts with rebates beginning at the start of next year. This would be a significant policy shift in the long-running battle between biopharma and hospitals over the federal drug discount program.

The revised pilot, which applies to drugs included in the first two rounds of Medicare price negotiations, comes after years of litigation and lobbying over concerns about duplicate discounts and program oversight. Although drugmakers are framing the move as one that will deliver greater transparency, hospitals are concerned it could deepen their financial strain and threaten care for low-income and rural patients.

“Rebates will make it harder for hospitals to access the resources Congress intended them to receive and easier for drugmakers to delay, diminish, or deny those resources,” said Maureen Testoni, who heads the trade group 340B Health, in a statement.

venture capital

TCGX launches $400 million Asia biotech fund

From STAT’s Allison DeAngelis: The money is flowing into biotech VC again, and TCGX is getting in on the action with a new Asia-specific fund.

The firm filed paperwork last week to raise $400 million for the new fund. This is on top of the $1.3 billion fund that TCGX — also known as TCG Crossover — announced it had raised last October.

The number of biotech investors that have raised new funds has been down significantly over the past couple of years, as their outside investors have itched for payouts of their investments, but haven’t found many. TCGX has made some money for its investors this year, though. The firm had a stake in Candid Therapeutics, which was acquired by UCB for around $2.2 billion. It also had equity in Aktis Oncology and Eikon Therapeutics, both of which went public through an IPO this year, with mixed results.

Biotech

BioNTech names new CEO

BioNTech named Guido Oelkers, formerly the leader of the Swedish biopharma company Sobi, as its new CEO, as the Covid-19 vaccine developer continues its shift to oncology.

Oelkers will replace Ugur Sahin as CEO. In March, BioNTech announced that Sahin and his cofounder and wife Özlem Türeci, the company’s chief medical officer, would depart the company to lead a new biotech focused on developing mRNA medicines.

drug pricing

Michigan court revives insulin pricing probe against Eli Lilly

The Michigan Supreme Court on Friday ruled 4-3 that Attorney General Dana Nessel can move forward with an investigation into Eli Lilly’s insulin pricing practices, STAT’s Ed Silverman writes. This overturns decisions made by a lower court that had blocked the probe.

The investigation was launched in 2022 under the state’s consumer protection law. It alleges that Lilly charged excessively high prices for several insulin products, forcing some patients to ration treatment or forgo it altogether.

Thanks for reading! Until tomorrow,

M&A

Is AstraZeneca exploring a massive merger with BMS?

vaccines

Moderna is set for a pivotal FDA flu vaccine decision

drug pricing

Contested 340B rebate pilot program is revised

venture capital

TCGX launches $400 million Asia biotech fund

Biotech

BioNTech names new CEO

drug pricing

Michigan court revives insulin pricing probe against Eli Lilly

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Thanks for reading! Until tomorrow,