AbbVie abandons I-Mab, CD47s

Today’s Big News

Sep 25, 2023

FDA’s no-holds barred objection to BrainStorm’s NurOwn on display days before advisory meeting


GSK manufacturing review prompts Scynexis to pull Brexafemme, halt trials over contamination concerns


AbbVie axes I-Mab pact to exit fast-thinning race for CD47 space


Enovis inks €800M deal for Italian orthopedics player Lima


Roche condemns 'act of counterfeiting' as authorities in Pakistan crack down on unapproved Avastin use

 

Featured

FDA’s no-holds barred objection to BrainStorm’s NurOwn on display days before advisory meeting

“Scientifically incomplete.” “Grossly deficient.” “Lacking scientific rigor.” These are just a few of the ways the FDA has described BrainStorm Cell Therapeutics’ application for the amyotrophic lateral sclerosis treatment NurOwn—a therapy that has already been rejected twice and is now getting its day before an agency advisory committee meeting after being filed over protest.
 

Top Stories

GSK manufacturing review prompts Scynexis to pull Brexafemme, halt trials over contamination concerns

Scynexis' drug launch is taking a severe detour after its 2021 approval. Monday, the company said it's pulling the medicine and halting trials over concerns of potential contamination.

AbbVie axes I-Mab pact to exit fast-thinning race for CD47 space

AbbVie has put I-Mab out of its misery. More than one year after scrapping a pair of clinical trials, the Big Pharma has cut its ties to the anti-CD47 antibody lemzoparlimab altogether and deprived I-Mab of the chance to pocket up to $1.3 billion in milestones.

Enovis inks €800M deal for Italian orthopedics player Lima

The transaction includes a 700 million euro payment in upfront cash, or about $741 million U.S., with the remainder made up in Enovis stock.

Roche condemns 'act of counterfeiting' as authorities in Pakistan crack down on unapproved Avastin use

Authorities in Pakistan are investigating the use of altered versions of Roche's Avastin after several diabetic patients who received a sham version of the drug lost their sight.

Revivicor sees 2 months of normal function from a xenotransplanted kidney-plus-thymus

United Therapeutics' Revivicor division has set its sights on human clinical trials in 2025 of its manufactured organs derived from genetically modified pigs.

Mission: Possible: Big Pharmas back star-fronted lung cancer awareness push

A who’s who of biopharma companies have backed a push to raise awareness about lung cancer among Hispanic and Latino Americans, funding a project that has enlisted a Mission: Impossible star to educate the community about risk factors, early warning signs and screening.

Morphic's stock sinks as phase 2 data on oral rival to Takeda's Entyvio disappoint

Investors have found a flaw in Morphic’s glittering EMERALD-1 trial. Months after raising $240 million on the back of top-line results that sent its stock soaring, the biotech has shared a fuller look at the data on its oral ulcerative colitis candidate and wiped out its earlier gains.

Vapotherm’s high-flow oxygen shows gains in childhood acute asthma study

Children brought to an emergency room with acute asthma symptoms—and who did not respond to initial drug treatments—received either standard oxygen or Vapotherm’s high-velocity air approach.

Coherus hits FDA hurdles for PD-1 drug, Neulasta biosimilar on-body injector

The road to an FDA nod for Coherus BioSciences’ China-made PD-1 inhibitor has been long and tortuous. Now, the FDA found a fresh problem at a clinical trial site for Coherus’ Junshi Biosciences-partnered toripalimab.

Novo Nordisk pays $60M for 3 preclinical assets as part of AI-powered cardio collab with Valo

Novo Nordisk may be enjoying a revenue boost courtesy of its next-gen diabetes and obesity drugs, but the company isn’t kicking back and counting the cash. Instead, the Danish Big Pharma is handing over $60 million to Valo Health in the hope that the Flagship-founded company’s AI expertise can reproduce the same success in cardiovascular disease.

Regulatory tracker: Eisai, Biogen's Alzheimer's disease drug wins approval in Japan

In this tracker, Fierce Pharma is recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Some of these updates may not meet the bar for standalone stories, but we think they are still worth mentioning.
 
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