The Latest
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5 drugs to watch as biotechs report Q2
Wall Street is keeping a close eye on new launches from Amgen, Gilead and Vertex as biotechs work to turn around an up-and-down 2018.
Marketing -
Mesoblast gets access to China though deal with Tasly
Through a $65 million deal, Mesoblast will expand into the Chinese market, while Tasly moves beyond its focus on traditional Chinese medicines.
Mergers and Acquisitions / Deals -
Hospitals 340B suit denied by federal appeals court
It was a lost round for hospitals, which are trying to stop the Trump administration's cuts to the discounts drug companies are required to give safety-net providers.
Regulatory / Compliance -
J&J: Growth not dependent on Zytiga
Execs said Q2 pharma sales would still have grown in the high single digits without help from the prostate cancer drug, which is facing generic competition.
Corporate News -
Roche experimental flu drug clears second Phase 3
The Swiss pharma has already submitted the antiviral for U.S. approval, with a decision expected by late December.
Clinical Trials -
Invokana renal trial stopped early for efficacy
A late-stage outcomes study could help reverse the fortunes of the multinational's aging diabetes medicine.
Clinical Trials -
CytoDyn touts new data in drug-resistant HIV patients
Even amid an acquisition and new interest in cancer, HIV is still the main focus for CytoDyn and its lead candidate.
Clinical Trials -
Cannabis-based drugs and devices: A winning combo?
Tetra Bio-Pharma and Storz & Bickel will collaborate to bring a marijuana-based drug, inhaled in an herbal vaporizer, to fibromyalgia patients in Canada.
Regulatory / Compliance -
Biogen looking to expand into medtech: report
The biotech is considering how imaging and data technologies could bolster its position in neurology, according to the Israeli paper Globes.
Corporate News -
Fake FDA warning letters may be part of new extortion scam
Criminals are targeting consumers who bought drugs online or via phone.
Regulatory / Compliance -
FDA approves first drug designed to treat smallpox
Siga Technologies developed TPOXX under a federal defense contract, amid fears of bioterrorism post 9/11.
Regulatory / Compliance -
Cassiopea prospects fill in as hair loss drug shows promise
The small biotech believes these results, while preliminary, show efficacy to compete with Propecia.
Clinical Trials -
Novartis' contacts with Trump lawyer broader than company let on, US senators charge
The Swiss pharma's relationship with Trump insider Michael Cohen was "longer and more detailed" that previously disclosed, say four top Democrats.
Corporate News -
Gilenya patent decision gives MS market a reprieve
A favorable decision from an IPR hearing could delay a generic version of Novartis' oral multiple sclerosis drug, potentially helping rivals as well.
Legal -
J&J taps German Merck to market Invokana in China
Diabetes became a major health issue in China over last few decades. Though that offers a big market opportunity, commercializing products remains tricky.
Mergers and Acquisitions / Deals -
Advaxis clinical hold lifted, but stock not so much
Prices of the dollar stock did rise at market's open Friday, yet it's a far cry from the biotech's 52-week high as pipeline concerns continue to weigh on investors.
Regulatory / Compliance -
More insurers using outcomes-based deals with drug, device companies
Cardiovascular, infectious diseases and oncology are the top three therapeutic areas where the contracts are used, according to an Avalere survey.
Marketing -
FDA creates task force to combat drug shortages
The group will look at factors such as payer reimbursement policies and incentives to encourage investment in manufacturing.
Regulatory / Compliance -
Novartis partners with French CDMO to bolster CAR-T supply
A deal with Cell for Cure is aimed at complementing the pharma's existing CAR-T production sites in New Jersey and Germany.
Manufacturing -
New epilepsy data sets Zogenix up for showdown with GW
More late-stage data showed patients with a rare form of epilepsy had greater reductions in monthly seizures when taking ZX008 compared to placebo.
Clinical Trials -
Enzyvant initiates value-based pricing talks ahead of filing
The "Vant" hopes to set up a deal with payers before a potential approval of its experimental one-time therapy for an extremely rare pediatric disease.
Regulatory / Compliance -
Dermavant finds 'cornerstone' drug in GSK's pipeline
The British pharma will out-license tapinarof, in testing for psoriasis and atopic dermatitis, to Dermavant for nearly $200 million.
Clinical Trials -
New FDA guidance aimed at advancing gene therapy
A suite of new and updated agency documents brings the prospect of more gene therapy approvals closer.
Regulatory / Compliance -
BioCryst nixes merger, sending Idera stock down
Both companies are trying to find a path forward after plans to join were dropped.
Mergers and Acquisitions / Deals -
Dova downgraded as high price tag threatens to slow new drug's pickup
The biotech believes Doptelet could tap into a multibillion dollar market, but some analysts question whether that could happen anytime soon.
Marketing