Idorsia hit the marketing ground running with its insomnia launch, debuting an awareness campaign starring popular “Friends” actress Jennifer Aniston just days after its Quviviq approval in January. Now the insomnia brand hit shelves this week with a sales force rollout to physicians, digital and social media ads and plans for a direct-to-consumer campaign coming soon.
A field team of about 500 sales reps plus another 100 customer-facing medical affairs, market access and others are reaching out to physicians in the first wave of Quviviq marketing, said Patricia Torr, president and general manager of Idorsia US. About 75% of the target group of doctors are primary care, with psychiatry and a few other specialties making up the rest.
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The Asia Pacific region, which has more than 6,772 trial sites each with access to an average of 2,136 million people, has considerable underutilized capacity presenting an opportunity for growth in multinational trials in the region.
Demand for Asia Pacific trial sites is strong with almost half of the more than 27,000 clinical trials initiated in 2021 having in Asia Pacific, according to the latest analysis from GlobalData in a new report titled State of the Global Biotech Landscape: Where the Opportunities Lie.
Roche let the air out of the TIGIT party balloon with a pair of crushing Phase III failures. Now Gilead $GILD and Arcus $RCUS are back with details of their closely-watched Phase II data in Stage IV non-small cell lung cancer, hoping to spark some renewed enthusiasm for their contender and the rest of the field.
But despite some positive results in frontline therapy for patients with high PD-L1 levels, plus a claim on a potential “new standard of care,” the mid-stage readout from the ARC-7 study won’t end the running debate that has blighted expectations for the target.
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Taysha Gene Therapies CEO RA Session II has resigned following a turbulent year in which the company shelved most of its rare disease pipeline and faced criticism from families for blocking plans to restart a drug program.
Session, who will remain a member of the board of directors, will be succeeded by Sean Nolan, the board’s chairman. The changes are effective immediately, Taysha said Friday in a news release. Nolan said his plans call for expediting the company’s lead programs and strengthening a recent partnership with Astellas that brought in $50 million.
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Madrigal Pharmaceuticals says its NASH drug, resmetirom, has met its early endpoints in a Phase III trial, marking a major success in a field littered with failures in recent years. Now, the company plans to submit for accelerated approval in the first half of next year, CEO Paul Friedman said in a statement.
The biotech’s stock $MDGL was up over 200% in pre-market trading, eclipsing the $200 mark. It had closed at just under $64 on Friday.
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Novartis is ringing in the new year with more job cuts, according to New Jersey state documents.
The pharma giant is axing 284 jobs in East Hanover, a township about 24 miles away from New York City. The cuts, which span Novartis Services, Novartis Pharmaceuticals and Novartis Corporation, take effect on Jan. 28, according to a notice posted last month in New Jersey’s state Worker Adjustment and Retraining Notification Act (WARN) system.
AbbVie CEO Richard Gonzalez wants to bring Vraylar to new heights. On Friday, regulators set the next phase of his plan in motion.
The FDA approved Vraylar, also known as cariprazine, as an add-on therapy for adults with major depressive disorder (MDD), one of the most common mental disorders in the US. That marks Vraylar’s fourth indication behind schizophrenia, the acute treatment of manic or mixed episodes in those with bipolar I disorder, and depressive episodes in bipolar I patients.
Boehringer Ingelheim inked a massive collaboration with digital therapeutics company Click Therapeutics two years ago — and now its expanding.
On Monday, the German pharma announced the launch of an “expanded collaboration” between Boehringer Ingelheim and Click to develop and commercialize a second “prescription-based digital therapeutic.” The collaboration will center on schizophrenia and aim to combine multiple therapeutic interventions for use with pharmaceutical therapy to help people with the disease.
The European Commission signed off on the continent’s first allogeneic T cell therapy Monday. And for its maker Atara Biotherapeutics, the approval marks the biotech’s first approved therapy.
Ebvallo, made by Atara Biotherapeutics, is now approved by the EMA for marketing authorization for a specific subgroup of patients with post-transplant lymphoproliferative disease who are positive for Epstein-Barr virus. The disease, also known as EBV+ PTLD for short, is a rare complication that can occur after a solid organ or hematopoietic stem cell transplant.
As several major drugs have been been in short supply this year, including Adderall and amoxicillin, now two drugs to help treat diabetes are joining them.
According to the FDA, Eli Lilly’s diabetes meds Trulicity and Mounjaro, listed as tirzepatide injections, are currently in shortage.
For Trulicity, the shortage has been reported in the 3 and 4.5 mg doses, with the FDA stating that shipments of those doses are occurring but due to high demand there may be periods of “back order.”
Bioscience & Technology Business Center
The University of Kansas
Lawrence, Kansas
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