PharmaWire

The European Commission has started formal proceedings in an antitrust investigation against Sanofi $SNY. The probe surrounds Sanofi’s marketing of its flu vaccine for at-risk seniors, Efluelda, and whether it “disparages” its lone rival in the indication, CSL Seqirus’ Fluad. pharmawire.org/blog/brussels-…

H.C. Wainwright lowered its price target on Alnylam Pharmaceuticals $ALNY to $470 from $510. The stock is down 41% from its 52-week high of $495.55, with shares falling 27% year-to-date. In June, $ALNY was reprimanded by the UK's PMCPA after $PFE complained that Alnylam promoted Amvuttra outside its licensed indication at the European Society of Cardiology 2024 congress. pharmawire.org/blog/hc-wainwr…

GLP-1 drugs from Pfizer $PFE and Innovent Biologics have passed a preliminary review to be potentially included in China's basic ​medical insurance drug catalogue, a move which could lead to lower treatment prices. pharmawire.org/blog/pfizer-an…

Zymeworks $ZYME has agreed to pay $929 million in cash for Theravance Biopharma $TBPH. The sale comes four months after Theravance shut down its R&D unit, laid off half its staff and signaled it was up for sale. pharmawire.org/blog/zymeworks…

The FDA has selected Eli Lilly $LLY, Regeneron $REGN and five ​other companies for a pilot program to speed up ‌reviews of new domestic pharmaceutical manufacturing facilities. pharmawire.org/blog/fda-picks…

Democrat-led states have sued to block a Trump administration rule implementing new work requirements for Medicaid recipients. They argued it unlawfully narrows exemptions for people with serious medical conditions. #Trump #Pharma pharmawire.org/blog/m8nah0wkb…

ATTR-CM player BridgeBio’s $BBIO stock jumped by over 15% after AstraZeneca’s Wainua missed its mark in its latest trial. This miss is huge news in the ATTR-CM market, projected to be worth up to $20 billion, and leaves just three players: $BBIO, $PFE, and $ALNY. ‘Stabilizers’, like $BBIO’s Attruby, are now positioned to win both first line and second line, with silencers like AstraZeneca’s Wainua relegated to third line. $BBIO is now set to dominate the market, and its stabilizing Attruby has a 95%+ stabilization rate, by far the best among its competitors.

$RHHBY and $NVS face a newly unsealed whistleblower lawsuit alleging a decades-long kickback scheme to boost sales of allergy drug Xolair. The 143-page suit also names $SAN, $REGN, $AZN, $AMGN and $GSK. pharmawire.org/blog/whistlebl…

BridgeBio’s $BBIO achondroplasia drug infigratinib boosts growth in children and significantly boosts body proportionality, according to a new study published in the New England Journal of Medicine. pharmawire.org/blog/bridgebio…

$MRK's tulisokibart met the primary endpoint in a late-stage trial, achieving clinical remission in ulcerative colitis patients at 12 weeks. The drug is currently being evaluated across seven diseases. pharmawire.org/blog/mercks-an…

$PFE and Flynn Pharma lost a UK Court of Appeal ruling after the court overturned a finding that the Competition and Markets Authority had used flawed reasoning in fining the pair £70m for charging excessive prices for epilepsy drug phenytoin. pharmawire.org/blog/uk-antitr…

South Africa's High Court blocked a local pharmacy group from manufacturing and selling weight-loss medicines containing semaglutide, the key ingredient in $NVO's Ozempic and Wegovy drugs. pharmawire.org/blog/south-afr…

$ABBV is acquiring $APGE for $10.9bn in cash, its biggest deal in over five years. $ABBV is seeking to bolster its treatment pipeline for inflammatory ‌diseases like atopic dermatitis and asthma. pharmawire.org/blog/abbvie-de…

Kardigan $KARD shares ​rose 31% above their initial public offering price after ‌the heart drug developer raised $400 million in an upsized US IPO. pharmawire.org/blog/kardigan-…

$RGNX shares rose 16% after the FDA indicated it will reverse its February rejection of Navsunli, a gene therapy for Hunter syndrome. pharmawire.org/blog/fda-rever…

$PFE's experimental drug sigvotatug vedotin missed the primary endpoint in a late-stage trial. The drug was acquired via the $43bn Seagen deal. pharmawire.org/blog/pfizers-e…

$ALNY was reprimanded by the UK's PMCPA after $PFE complained that Alnylam promoted Amvuttra outside its licensed indication at the European Society of Cardiology 2024 congress. pharmawire.org/blog/alnylam-r…

Baby formula maker Nara Organics said it is voluntarily recalling all of its infant formula, currently available in the United States, over potential risk of bacterial contamination. In May, New Zealand's a2 Milk $A2M, recalled three batches ⁠of its a2 Platinum formula sold in the United States after detecting the toxin cereulide. pharmawire.org/blog/nara-orga…

Novo Nordisk $NVO plans to seek Chinese regulatory approval for ‌its Wegovy weight-loss pill "very soon," CEO Mike Doustdar said, as it makes efforts to catch up with rival Eli Lilly $LLY. pharmawire.org/blog/novo-nord…

In a major win for the California Biopharma company, BridgeBio $BBIO scored $1 billion of financing from Sixth Street Partners and KKR. The transaction has an initial conversion price of around $138 per share, which is well above current trading levels, and is a clear vote of confidence in BridgeBio’s rare disease pipeline and huge potential. The deal gives BridgeBio substantial new funding to accelerate the launch of new genetic disease therapies, strengthening its position as one of biopharma’s most promising growth stories. pharmawire.org/blog/byqrv47f6…