| | Whitepaper: Early engagement & regulatory considerations for emerging biotechs Despite robust funding and government initiatives for the development of orphan drugs and personalised medicines, small and emerging biotechs are typically very lean on resources, lacking the infrastructure required to bring their innovation to the market. Gain insight into the common questions small and emerging biotech companies face, and the importance of early engagement and regulatory affairs when developing an asset and considering a drug development partner. Learn more. |
Harpoon drug sunk by modest activity, challenging tolerability, forcing pivot from prostate cancer prospect Orphazyme on last leg as court-mediated restructuring drives another wave of layoffs Capricor culls COVID-19 vax work but eyes phase 3 for Duchenne therapy AbbVie doubles down on Gedeon Richter pact that brought Vraylar to the world Immunome's COVID-19 antibody cocktail back on track for phase 1 after FDA lifts hold Histogen seeks to tear up COVID-19 R&D pact and go solo, accuses Amerimmune of failing to push on into phase 2 MorphoSys cans US R&D to consolidate work in Germany, taking $254M charge BeiGene, Hutchmed, Zai Lab tagged for potential US delisting under SEC audit rules, with more Chinese biotechs likely to face scrutiny FDA slams Philips' 'inadequate' efforts to notify patients, suppliers of CPAP recall AbbVie touts Qulipta chronic migraine win as Biohaven duel heats up Exact Sciences enlists Katie Couric for new commercial to promote Cologuard, colorectal cancer screening Surgical robot maker Memic backtracks on SPAC pact Fierce Pharma Asia—Legend CEO's cell therapy ambitions; Indian pharmas' awkward position; new Hutchmed CEO Chutes & Ladders—Janssen's US oncology lead jumps to Teon as CEO Featured Story | By Nick Paul Taylor Harpoon Therapeutics has given up on its onetime lead prospect HPN424. A phase 1/2a prostate cancer clinical trial found the PSMA-targeting T-cell engager had “modest activity with a tolerability profile that has been challenging,” driving Harpoon to discontinue development and focus on other assets. read more |
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Top Stories By Max Bayer The wheels are almost entirely off Danish biotech Orphazyme after the company’s board of directors called for a court-mediated restructuring, prompting the second round of layoffs in less than a year—this time for half of the global staff. read more By Kyle LaHucik Capricor Therapeutics will get enrollment underway in a phase 3 trial for its Duchenne muscular dystrophy cell therapy next quarter, while development of a COVID-19 vaccine is coming to a halt. read more By Annalee Armstrong They worked together before on bipolar medication Vraylar, and now Allergan—ahem, AbbVie—will try to repeat that success with Gedeon Richter. AbbVie, which of course absorbed Allergan two years ago, announced it will continue its partnership with the Hungarian pharmaceutical company to create dopamine receptor modulators for neuropsychiatric diseases. read more By Max Bayer Immunome’s antibody cocktail COVID-19 treatment is free from an FDA hold, two months after the pause was first placed. read more By Nick Paul Taylor The collaboration between Histogen and Amerimmune has soured. Believing Amerimmune has failed to meet its R&D responsibilities, Histogen is seeking to terminate the collaboration agreement and retake control of the COVID-19 development program. read more By Max Bayer MorphoSys is axing its early pipeline and U.S. R&D work that came with the $1.7 billion purchase of Constellation Pharmaceuticals, which will mean a more than $250 million impairment charge as the German pharma shifts work home. read more By Angus Liu The U.S. securities watchdog has set the countdown timer for the delisting of three leading Chinese biotechs from the Nasdaq as a newly installed foreign audit law threatens to banish more Chinese firms from the U.S. stock market. read more By Andrea Park Nine months into Philips’ wide-ranging Class I recall of many of its CPAP and BiPAP machines and other respiratory devices, the FDA isn’t entirely pleased with how the company has handled the recall. read more By Angus Liu Oral CGRP inhibitors made by AbbVie and Biohaven are quickly gaining share in the migraine market. But unlike their injectable peers, the two oral options have their prevention labels limited to episodic patients. That might change soon with new data from AbbVie's Qulipta. read more By Natalie Missakian It’s been 22 years since Katie Couric famously got a colonoscopy live on the "Today" show, sparking a surge in colon cancer screenings that doctors nicknamed “the Katie Couric effect.” Will she give a similar boost to Exact Sciences’ at-home screening kit Cologuard? read more By Andrea Park For the second time in as many months, a medtech maker with visions of the public market has pulled out of a lucrative reverse merger deal. read more By Angus Liu Legend Biotech CEO talks about its cell therapy ambitions. The Indian government's reluctance to take a harsh stance on Russia could backfire for its pharma industry. Hutchmed unveiled a new CEO as its first FDA decision nears. And more. read more By Kyle LaHucik Teon Therapeutics poached Johnson & Johnson's Janssen U.S. oncology leader Serge Messerlian to be CEO. BeiGene's hematology chief medical officer Jane Huang, M.D., resigned to become CMO of Prelude Therapeutics. And ex-Adastra Pharmaceuticals CEO Scott Megafinn is now chief of Morningside's Adiso Therapeutics. read more Resources Sponsored by: H1 Read why many MSLs are still challenged in developing integrated strategies to increase the volume of meaningful engagements. Download this industry report to find out what the top challenges are and suggestion strategies to solve them. Download now. Sponsored by: Oracle Health Sciences Learn about ways to break down regulatory roadblocks and get closer to 100% clarity on regulatory positions to advance decentralized clinical trials in research. Sponsored by: Oracle Health Sciences How to overcome top challenges faced in decentralized trials. Sponsored by: United Cargo The United Cargo team has made a commitment to pharmaceutical and medical partners that we are equipped to support their vaccine transportation needs safely and effectively across our expansive global and domestic network. The safety and security of these commodities is our priority, and we are proud to be a trusted partner in these efforts. Download infographic now. Sponsored by: Catalent How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market? Sponsored by: Catalent Learn more about how the versatility of Softgel Technology helped a customer with a volatile compound. Sponsored by: Catalent What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations? Sponsored by: Catalent Biologics Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar. Sponsored by: Catalent Biologics Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care. Fierce BD&L Summit for Life Sciences March 15-16, 2022 | San Francisco, CA Fierce Promotional Review Committee Compliance and Best Practices Summit April 12-14, 2022 | New Brunswick, NJ Fierce Trial Master File Summit May 2-4, 2022 | New Orleans, LA & Streaming Live Fierce Pharma PR & Communications Summit West June 14, 2022 | Huntington Beach, CA Fierce Digital Pharma Engage June 14-15, 2022 | Huntington Beach, CA Fierce Digital Pharma Innovation Week June 21-23, 2022 | Virtual Event Fierce Pharma PR & Communications Summit July 2022 | Location TBD (NYC Metro Area) Fierce MedTech Summit August 8-9, 2022 | Minneapolis, MN Promotional Review Committee Compliance and Best Practices Summit West (PRC West) September 2022 | San Diego, CA Medical Affairs Strategic Summit (MASS West) September 2022 | San Diego, CA Fierce New Product Planning Summit September 20-22, 2022 | Boston, MA Fierce Digital Pharma East October 18-20, 2022 | Philadelphia, PA & October 25-28, 2022 | Virtual Event Fierce Biotech Cell & Gene Therapy Forum October 19, 2022 | Virtual Event Fierce Pharma Marketing Awards October 19, 2022 | Philadelphia, PA Fierce Pharma Meeting Professionals Summit November 2-3, 2022 | Atlantic City, NJ Fierce European Trial Master File Summit November 14-16, 2022 | London, UK Fierce Launch Readiness for Medical Affairs & Communications Teams Summit November 30-December 1, 2022 | Virtual Event Fierce JPM Week 2023 January 2023 | San Francisco, CA & Virtual | 