After Roe ruling, Perrigo's HRA Pharma asks FDA to make its birth control pill available OTC MacroGenics closes solid tumor clinical trial after 7 people die Medtronic begins Class I recall of 1 million dialysis catheters at risk of leaking Sponsored: Decentralized clinical trials, patient experience and the role of supply chain management Executive Spotlight—Northwell Health's Michael Dowling on 'good politics' and perseverance in health leadership Brace yourself, Amgen. Lumakras' sales might disappoint as key data readouts draw near, analyst warns Vertex absorbs ViaCyte and its stem cell-based diabetes treatment for $320M, clearing out competition FDA denies Lumos Diagnostics' bid for rapid test to differentiate between bacterial, viral infections CVS names new chief data, digital and technology officer After Democrats unveil drug price negotiation plan, industry blasts it as 'misguided' Roche hands over $55M for licensing rights to Ionis’ kidney disease candidate Smith+Nephew aims to give its reps a surgeon’s-eye view through wearable smart glasses California will tackle high drug prices by making its own low-cost insulin, Newsom says Hologic, Thermo Fisher launch molecular tests in EU for multiple respiratory viruses at once 'Organize. Align': Women in biotech see Roe v. Wade ruling as a call to action Featured Story | By Fraiser Kansteiner Two manufacturers of contraceptive pills have been jockeying for FDA clearance to sell their medications over the counter for more than half a decade. Now, against the backdrop of an intense debate over reproductive rights, one of those drugmakers is officially in the running for an approval. read more |
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Top Stories By Nick Paul Taylor MacroGenics has closed a phase 2 clinical trial of its anti-cancer antibody enoblituzumab after learning of seven deaths potentially associated with hemorrhagic events. The setback means two of MacroGenics’ three attacks on B7-H3 have hit setbacks but the biotech is forging ahead with the third candidate. read more By Andrea Park Medtronic has asked healthcare providers to immediately stop using more than 1 million catheters distributed across the U.S. and around the world after discovering a potential safety risk within the devices. read more Sponsored By: Parexel The rise of clinical trial complexity has been well-documented but the impact on logistics is not well understood. Here, we look at decentralized trials, patient experience and the role of logistics. read more By Dave Muoio Northwell Health's president and CEO says the role of a leader is to ensure vying parties "coalesce around common values, programs and missions." He also stressed the need for healthcare organizations to remain committed when tackling complex, long-term goals such as Black maternal mortality. read more By Angus Liu Amgen’s first-in-class KRAS inhibitor Lumakras has been grabbing attention even before its approval. Now, after closely watching the drug’s commercial performance in non-small cell lung cancer, one team of analysts is sounding an alarm ahead of key clinical trial data readouts. read more By Max Bayer Just a week after Vertex’s stem cell therapy to treat type 1 diabetes was released from an FDA clinical hold, the company is clearing out potential competition by buying ViaCyte for $320 million. read more By Andrea Park Lumos Diagnostics’ FebriDx point-of-care test will have to wait a bit longer to see the light of day in the U.S., as the Australian company announced Monday that its 510(k) submission to the FDA has been rejected. read more By Paige Minemyer Tilak Mandadi will step into the position on July 25, and in the role will lead the healthcare giant's strategy around data, digital and technology, CVS said. read more By Fraiser Kansteiner Legislation aimed at slashing high U.S. drug costs could undercut its own goals by depriving drugmakers of incentives for developing blockbuster medicines, plus lower-cost biosimilars and generics, several analysts and industry groups have warned. read more By Gabrielle Masson Roche is handing over $55 million for the licensing rights to Ionis Pharmaceuticals’ rare kidney disease treatment candidate, an investigational med that the Big Pharma will advance into a phase 3 clinical trial. read more By Conor Hale By working with medical headset maker Rods&Cones, Smith+Nephew hopes to offer technical support and real-time troubleshooting for its products from anywhere in the world. read more By Dave Muoio Gov. Gavin Newsom announced on Twitter that a recently signed state budget allots $100 million for California to contract and make its own insulin. read more By Andrea Park Cold and flu season may still be several months away in the northern hemisphere, but diagnostic test makers like Hologic and Thermo Fisher Scientific are taking no chances. read more By Annalee Armstrong More than 100 women in biotech have signed on to a letter decrying the Supreme Court's ruling overturning Roe v. Wade. They say this is only the beginning of their activism. read more Resources Sponsored by: Cognizant Explore how Cognizant SIP helped Roche streamline its global feasibility process. Sponsored by: Blue Matter Consulting For an emerging biopharma company, Europe can be very attractive. But it can also be complex and confusing. This e-book covers the 12 most common pitfalls for companies entering European markets for the first time, offering guidance to help growing companies avoid them and succeed. Sponsored by: CG Life Explore the new cell therapy handbook from Thermo Fisher Scientific. Sponsored by: Catalent What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations? Sponsored by: Thermo Fisher Scientific Sponsored by Thermo Fisher Scientific The journey for starting or expanding a lab can be exhilarating, while also being challenging--learn how this free program provides savings and solutions to support your goals. Sponsored by: Catalent Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care. Sponsored by: Catalent What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? | 