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With no Alzheimer's update, attention turns to Biogen's troubles
Spinraza competitors and Tecfidera patent challenges were in the spotlight as Biogen provided few details about its planned filing for aducanumab.
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Amgen, Pfizer biosimilar sales pressure top drugs
Competition is heating up for copycats to Roche's top-selling cancer drugs, as the U.S. biosimilar market shows some modest signs of shifting.
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Biotech lacking diverse leadership, top trade group admits
Too few women and people of color are in executive positions or on the boards of biotech companies, according to a new report from BIO.
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Preventive Alzheimer's trial data due within weeks, Lilly says
Lilly's top scientist, however, set low expectations that solanezumab will show a benefit for patients with genetic mutations that drive early and severe disease.
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Zolgensma sales grow, signaling gene therapy momentum
Another 100 infants received Novartis' gene therapy in the fourth quarter, supported by broad insurance coverage and more newborn screening.
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Decibel CEO steps down as company pares workforce
The Third Rock-backed company put an acting executive in place as it repositions for development in gene therapy and regenerative medicine.
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Novartis gives up on Advair generic, leaving Mylan as sole competitor
Development delays and an uncertain path forward led Novartis to discontinue further work on its knockoff version of the GlaxoSmithKline lung drug.
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5 biopharmas to watch as the decade's last earnings kick off
Biogen faces down analysts one more time on its aducanumab plans, while two biotechs could give early glimpses into their first-ever drug launches.
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Pfizer lays out gene therapy aspirations
With more Phase 3 trials on the near horizon, the big pharma plans to add one new gene therapy project per year to its pipeline.
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Acceleron soars on blood pressure data despite lengthy road to market
While the biotech's drug succeeded in a mid-stage study of pulmonary arterial hypertension patients, analysts think a potential approval is four years off, at least.
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FDA, expecting a gene therapy boom, firms up policies
In seven guidance documents, the agency gave drugmakers guidelines on manufacturing, testing and long-term follow-up for the one-time treatments.
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J&J launches vaccine efforts as coronavirus spreads
The pharma says it has the manufacturing capacity to produce a vaccine at scale should its scientists hit upon a construct that appears effective.
UPDATED: Jan. 27, 2020 at 4:51 p.m. -
To close merger, AbbVie and Allergan sell digestive drug to AstraZeneca
Allergan acquired global rights to brazikumab for $250 million up front in 2016, but expected antitrust conflicts pushed it and AbbVie to pursue a divestment.
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Pfizer hits its biosimilar stride
The big pharma, which has criticized other companies for stifling the U.S. biosimilars market, is now poised to launch three of these copycat biologics in as many months.
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FDA decision nears on Aimmune's contested peanut allergy drug
Palforzia is one of two products under review by the FDA that are aimed at desensitizing people highly allergic to peanuts.
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Ipsen pauses studies of drug for rare bone disease
The decision makes a mid-2020 approval and launch, which Ipsen expected when it acquired the drug, less likely.
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Epizyme drug granted approval by FDA for rare cancer
Five years after buying back rights from Eisai, Epizyme won approval for its first-ever drug.
UPDATED: Jan. 24, 2020 at 11:38 a.m. -
Roche strengthens case for SMA drug with new study data
Results showed the oral drug can help improve motor function in babies with the severest form of a rare degenerative muscular disease.
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Safety risks highlighted in FDA letter on Sarepta's Vyondys
In rejecting Vyondys last August, one FDA official wrote that, without confirmatory trials for either of Sarepta's muscular dystrophy drugs, it's difficult to judge whether they're worth the risk.
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AstraZeneca pledges to go 'carbon negative' by 2030
Matching a recent commitment from Microsoft, AstraZeneca says it's stepping up its climate efforts. Recent numbers show the pharma has a ways to go.
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Drug trial success a consolation prize for Akcea, Ionis
Although Novartis chose not to license Akcea and Ionis' high triglyceride drug, positive data could open up new development opportunities.
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Blue Cross Blue Shield partners with Civica on generic drug mission
The Blue Cross Blue Shield Association, along with 18 affiliate companies, will invest $55 million to create a new unit of the generic drug company.
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BeiGene cancer drug data sets up China duel with Merck
Merck's Keytruda won the first PD-1 approval in China for a type of lung cancer, but Beigene's tislelizumab could make a run.
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After big year, RNAi drugmakers compete to prove what comes next
"We are in the first out of the first inning of the lifespan of RNAi," said Arrowhead CEO Christopher Anzalone. Two RNAi drugs are now approved, but the field still has much to prove.
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While expected, Intercept's approval delay adds to NASH uncertainty
An upcoming FDA advisory meeting will be a key test for Intercept's ambitions to become the first drugmaker with an approved therapy for the liver disease.
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