Calliditas Therapeutics AB’s full approval from the U.S. FDA for Tarpeyo (budesonide) delayed release capsules in immunoglobulin A nephropathy (IgAN) revived speculation about competitor Travere Therapeutics Inc. which, like Calliditas, has gained accelerated approval for its prospect. Read More
Receiving a second complete response letter (CRL) from the U.S. FDA for gefapixant to treat refractory and unexplained chronic cough – an indication for which there are no approved treatments in the U.S., Merck & Co. Inc. said it is reviewing the agency’s feedback to determine the next steps, if any, for the oral selective P2X3 receptor antagonist. Read More
Pharma companies facing the pricing pressures unleashed by the U.S. Inflation Reduction Act will find little respite in European markets in 2024, as governments erect higher market access hurdles around pricing and reimbursement in a bid to constrain drug budgets. Read More
South Korean biotech Pinotbio Co. Ltd. inked a $250 million (₩320 billion) licensing deal with Princeton, N.J.-based Conjugatebio Inc. to develop 10 antibody-drug conjugate (ADC) targets with Pinotbio’s ADC platform technology. The deal announced on Dec. 21 adds to a previous agreement between the two companies last year. Pinotbio and Conjugate first teamed up to discover and develop five ADC targets in June 2022. Read More
Following the decision of Australia’s Therapeutic Drugs Administration to allow prescribing of MDMA for post-traumatic stress disorder and psilocybin in treatment-resistant depression from July 2023, and with U.S. FDA approval of MDMA for treating PTSD expected in 2024, the EMA is under increasing pressure to set out a path to approval for psychedelics. Read More
With the clock ticking down on 2023, the U.S. FDA seems to be scurrying to push final guidances out the door before the new year. This week, the agency has finalized several guidances, ranging from the development of monoclonal antibodies to treat or prevent COVID-19 to the use of real-world data in drug development. Read More
A threat to biopharma innovation arrived at a larger scale in 2023 in the form of greater U.S. FTC scrutiny, calling into question the legitimacy of certain M&As and deals. Read More
Nearly four years after the COVID-19 pandemic closed government offices and sent federal employees home to work remotely, the U.S. FDA is returning to some semblance of normalcy, with its drug and biologics centers expanding in-person face-to-face industry meetings to include all PDUFA and BsUFA meeting types, beginning Jan. 22. Read More
One aspect of 2023 our group of executives completely agreed on: the past year was tough financially. And they all foresee a more vibrant year ahead for the market. Giving all of them hope were technological breakthroughs such as artificial intelligence, game changing weight loss drugs, the surging fascination with ADCs and hope for lower interest rates. But uncertainty looms about the upcoming general election in the U.S. and ground-shifting gene therapies. Read More
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New hires and promotions in the biopharma industry, including: Acelyrin, Alterity, Disc Medicine, Edenbridge, Eterna, Hervolution, Lift, Myriad Genetics, Pacira. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Atara, Barinthus, Alexion, BIRAD, Cstone, DMK, Exscientia, Gilead, Hookipa, Janssen, JCR, Meiragtx, Pierre Fabre, Pluri, Sanofi, Servier, Takeda, US Worldmeds. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aurinia, Cellvax, Chiesi, Iama, Impact, Ocelot, Pfizer, Uvax. Read More
