Despite an FDA advisory committee’s narrow ruling that Provention Bio Inc.’s teplizumab has benefits that outweigh the risks in treating diabetes, the agency sent the company a complete response letter (CRL) regarding the diabetes therapy’s priority BLA. The CRL came the evening of July 2, Provention said, the PDUFA date that had been set months before. Read More
In a new chapter for the ongoing story of sodium glucose transporter-2 inhibitor (SGLT2) inhibitors, Boehringer Ingelheim International GmbH and Eli Lilly and Co.'s Jardiance (empagliflozin) has become the first therapy of the class to significantly reduce the risk of cardiovascular death or hospitalization vs. placebo for heart failure patients with preserved ejection fraction (HFpEF). The finding comes from the phase III Emperor-Preserved study, which tested once-daily Jardiance 10 mg vs. placebo in nearly 6,000 adults living with HFpEF, with and without diabetes. Read More
Advaxis Inc.’s long journey is ending happily by way of a merger with Biosight Ltd. that leaves the new firm with $50 million to help advance aspacytarabine (BST-236), a prodrug of cytarabine for acute myeloid leukemia and myelodysplastic syndromes. Read More
The U.S. Supreme Court has agreed to take up one piece of the 340B conundrum that’s pitting biopharma against hospitals and catching the Department of Health and Human Services in between. The case the court agreed to hear, the American Hospital Association (AHA) v. Becerra, focuses on whether HHS has the authority to cut Medicare reimbursement rates to reflect the steep discounts 340B hospitals get on certain prescription drugs. Read More
Just five days after raising $105 million in a series E financing round, RNA interference therapeutics specialist Sirnaomics Inc. obtained another IND approval from the FDA for its dual-targeting small interfering RNA (siRNA) inhibitor STP-707 to start a basket study in oncology. Sirnaomics’ CEO Patrick Lu told BioWorld in an exclusive interview that an I.V. administration of STP-707 will be tested to tackle solid cancers that may have metastasized into other potential areas or tissue types in the body. Read More
Compass Pathways Ltd. has joined with a U.K. hospital and an academic establishment to research the role of psychedelic medicine in new models of mental health care. The London-based company signed a memorandum of understanding with South London and Maudsley NHS Foundation Trust and the Institute of Psychiatry, Psychology and Neuroscience at King’s College London to launch the project. Read More
The U.S. Federal Trade Commission (FTC) reported a series of moves recently that promise more scrutiny of companies in the life sciences industry, such as the more routine use of subpoenas and other compulsory processes during investigations. However, the FTC has also announced a broader revamp of the agency’s rulemaking authorities that some critics argue would allow the commission to promulgate rules that are in defiance of standing FTC practice. Read More
In June, Morphosys AG acquired Constellation Pharmaceuticals Inc. in a deal worth $1.7 billion in which the German biotech monetizes a royalty from a big-selling antibody, spending the lump sum on research into small-molecule BET inhibitors. It’s a bold move and one that perhaps demonstrates a renewed interest in small-molecule drugs after a period when antibody-based molecules have been the dominant force in the market for branded drugs. Read More
LONDON – Following on from the $25 million up-front payment received on sealing their recent research collaboration, Mina Therapeutics Ltd. is now in line for a $15 million equity investment from Eli Lilly and Co. Inc. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Arrowhead, Gan and Lee, J&J, Krystal, Nicox, Philogen, Rallybio, Roche, Sab, Transcenta, Zydus. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 4D, Agenus, Arbutus, Auris, BMS, Cellgenix, Defence, Destiny, Denovo, Lipidor, Lundbeck, Mandos, Merck, Regeneron, Sartorius, SK Chemicals, Standigm, Vaccitech, Vtesse. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advicenne, Agenus, Bristol Myers Squibb, Cytodyn, Diurnal, Hangzhou Chance, Iterum, Moderna, Recipharm, Zydus Cadila. Read More
