The Latest
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To patients, Sarepta repeats message on surprise rejection of Duchenne drug
But company CEO Doug Ingram won't release text of the FDA's letter that cited Vyondys' safety risks, saying he wishes to be "respectful" to the agency.
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AstraZeneca lung cancer miss is Merck's gain
While Imfinzi is well established in early treatment, showing benefit in the metastatic setting has proven difficult, with survival data from NEPTUNE the latest stumble.
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Pfizer injects $500M more into gene therapy manufacturing
The money is going toward a North Carolina plant that will make the inactivated viruses used to deliver gene therapies and employ 300 staff.
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Sarepta now needs flawless progress for gene therapy
An unexpected rejection for the biotech's Vyondys 53 puts investor focus even more tightly on the biotech's earlier-stage muscular dystrophy pipeline.
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NHS coverage opens up Hemlibra to thousands more patients
The decision could help Roche's hemophilia drug make headway in the European market, especially among patients without inhibitors.
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AstraZeneca diabetes drug posts more positive heart data
Fewer patients with a history of heart issues died from a cardiovascular event or experienced worsening heart failure when taking Farxiga.
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Endo reaches $10M settlement in Ohio opioid case
The deal is with two Ohio counties that are part of a sweeping, multi-district litigation against opioid manufacturers.
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FDA boxed warning for AbbVie's JAK inhibitor clouds Gilead's
AbbVie and Gilead both expect billion-dollar sales from their arthritis drugs. But regulatory cautions on safety could weigh on those plans.
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Nabriva wins FDA's favor on pneumonia antibiotic
Xenleta is the biotech's first approved drug, but now faces a tough commercial challenge in a market dominated by generics.
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Amgen biosimilar debut boosted by UnitedHealthcare coverage switch
Recently launched Mvasi and Kanjinti, copycat versions of Avastin and Herceptin respectively, will be preferred products for the insurer starting October 1.
UPDATED: Aug. 19, 2019 at 2:01 p.m. -
Sarepta Duchenne drug rejected by FDA in surprise setback
Regulators cited infection risk and preclinical kidney toxicity as reasons for the Complete Response Letter to Sarepta, which had hoped to expand its offerings for the muscular dystrophy.
UPDATED: Aug. 19, 2019 at 6:44 p.m. -
Meet the protein responsible for nearly $100B in cancer drug deals
Kinase-inhibiting drugs like Vitrakvi, Imbruvica and Rozlytrek were at the heart of 20 M&A deals over the past decade, according to a new SVB Leerink report.
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Price, safety will test blockbuster billing for AbbVie's new arthritis drug
Rinvoq adds another oral option to rheumatologists' tool kits, but at a list price of $59,000 per year.
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Novo faces shareholder suit over insulin sales disclosures
Filed in Danish court, the securities lawsuit claims Novo misled investors and demands $1.75 billion.
UPDATED: Aug. 16, 2019 at 1:41 p.m. -
Celgene wins approval for drug key to Bristol buyout
Inrebic, which Celgene acquired in 2018 via its acquisition of Impact Biomedicines, is now approved for adults with a certain type of myelofibrosis.
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Roche cancer drug the 3rd approved for pan-tumor use
Entrectinib, which will be sold as Rozlytrek, joins Bayer's Vitrakvi as a treatment for solid cancers featuring a rare genetic fusion.
UPDATED: Aug. 15, 2019 at 6:15 p.m. -
CMS chief declines to provide details on Trump healthcare plan
Seema Verma did reiterate Thursday, though, the agency is pressing forward on the proposed plan for an International Pricing Index, calling it a "top priority."
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Nonprofit under pressure to make new TB drug affordable
Doctors Without Borders is calling on the TB Alliance to set a low price for the drug, and to put money from a sale of a regulatory fast pass toward patient access.
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Regeneron gets cholesterol drug win where Praluent won't go
The experimental therapy cut "bad" cholesterol levels almost 50% compared to placebo in patients with a hard-to-treat metabolic disorder.
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Novartis replaced AveXis chief scientist, R&D head amid Zolgensma uproar
Neither Brian Kaspar nor his brother Allan has been involved in AveXis operations since early May, when the Swiss pharma says it confirmed inaccuracies in the gene therapy's data.
UPDATED: Aug. 14, 2019 at 3:18 p.m. -
Lawmakers charge Mylan, Teva obstructed 2014 drug pricing probe
Renewing demands for information, Sen. Bernie Sanders and Rep. Elijah Cummings say Teva, Mylan and Heritage coordinated to "stonewall" past inquiries.
UPDATED: Aug. 16, 2019 at 10:27 p.m. -
Lilly bests J&J, with implications for AbbVie's new immunology star
A study of psoriasis patients found Lilly's Taltz outperformed J&J's Tremfya, which works the same way as AbbVie's new-to-market offering, Skyrizi.
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Pharming deal shows there's still life in struggling cancer drug class
For $20 million, the Netherlands-based company gets access to leniolisib, a PI3K inhibitor developed by Novartis.
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Study success strengthens case for Lynparza in ovarian cancer
Lynparza, approved since December as a first-line maintenance therapy in the tumor type, is now supported by positive results from a second trial in that setting.
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Amgen resurgent as court victory for top drug eases doubts
Shares in Amgen rose to their highest level in the past year as a favorable ruling makes Enbrel sales through 2029 more secure.
