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| 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. |
- Mirati's 'very big' KRAS drug gets December decision date, further extending Lumakras' first-mover status
- After a year as Merck KGaA healthcare CEO, Guenter reflects on I-O bispecific flop, spots new multiple sclerosis strategy
- Sage, Biogen score on phase 3 depression trial, but we still don't know about durability
- Sponsored: A New Way to Access Scientific Papers?
- Gilead comes back around on Hookipa HIV partnership, signing away $15M upfront and more down the line
- Electra, one of 2 Star biotechs, snags $84M to apply brakes to 'immune system haywire'
- Third Harmonic Bio raises $105M in series B to push hives treatment through phase 1b
- Single-asset Equillium buys Bioniz for up to $329M, adding 3 drugs to its pipeline
- Merck gets ahead of the Curve, inking oncology and neurology drug discovery deal with emerging British biotech
- UCB, Novartis and more pile into SpliceBio series A, ponying up $57M to tackle a big barrier to gene therapy
- Cytokinetics drug fails late-stage trial testing exercise capacity, as FDA considers nod in heart failure
- A new SPAC decides to enter murky waters to hunt for biotechs in downsized $75M IPO
- Biotech pipeline is outpaced by antibacterial resistance, new BIO report says
- Moderna plots 4 new Asia branches, local hiring spree to build its commercial footprint for life beyond COVID shots
- Veracyte’s prostate cancer genomic test can guide patients to best treatment, study finds
Featured Story | By Kyle LaHucik Mirati Therapeutics anticipated a second quarter decision for its KRAS lung cancer drug adagrasib, but the FDA squandered those hopes with a December decision date. That doesn't spell complete doom: the decision could come earlier (as it did three months sooner for Amgen's Lumakras), and the drug could still beat Amgen's med in other indications. read more |
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Top Stories By Angus Liu Just a few days after Peter Guenter joined Merck KGaA as its healthcare CEO at the beginning of 2021, the 22-year Sanofi veteran found himself picking up the pieces from the high-profile flop of then-GlaxoSmithKline-partnered PD-L1 bispecific, bintrafusp alfa. He has come out with an important lesson learned. read more By Annalee Armstrong Sage and Biogen’s depression drug quickly relieved symptoms of depression in a phase 3 trial, but the readout did little to quell concerns about the med’s durability of effect, an issue that investors and analysts have been concerned about. read more Sponsored by: DeepDyve For researchers unaffiliated with an academic library, finding scientific papers can be time-consuming and expensive—and organizing or sharing them can be even harder. Can a new tool address this gap? read more By Kyle LaHucik After backing away from an HIV treatment collaboration with Hookipa Pharma last fall, Gilead is back in the saddle. The two have amended their license agreement in a deal that gives the Austrian biotech $15 million upfront and up to $237 million in biobucks. read more By Kyle LaHucik Electra Therapeutics, a member of the Star Therapeutics constellation, is going to be reaching for some of the 7,000 rare diseases thanks to a new $84 million series B financing. read more By Max Bayer Third Harmonic Bio raised more than $105 million from its series B round as it looks to further develop its treatment for hives. The company says the money raised is enough to fund the develop the drug through phase 1b trials slated for later this year. read more By Kyle LaHucik Equillium will pay up to $329 million to acquire Bioniz to beef up its one-asset pipeline to go into lymphoma, celiac disease, balding and other indications. This is not the first time Bioniz has been approached by suitors: Spanish pharma Almirall opted not to acquire the biotech in the first half of 2021. read more By Nick Paul Taylor Merck has wandered off the beaten path to find a partner that can help it discover small molecule drug candidates against tough oncology and neurology targets. The deal sees Curve Therapeutics, working out of a site on the U.K.’s south coast, team up with Merck in a deal worth up to $1.7 billion. read more By Nick Paul Taylor SpliceBio has raised €50 million ($57 million) from a starry syndicate to tackle one of the biggest barriers in gene therapy. Armed with the series A funds, the Barcelona-based biotech will advance gene therapies based on a platform that could bypass the cargo capacity of adeno-associated vectors (AAV). read more By Kyle LaHucik Cytokinetics' heart failure drug omecamtiv mecarbil failed to improve exercise capacity in patients with a certain kind of heart failure in a phase 3 study. The trial is not part of the package that the biotech sent to the FDA for a Nov. 30 decision on the drug. read more By Kyle LaHucik Genesis Unicorn Capital has landed on the Nasdaq, a whole 12 months after incorporating, with a $75 million Wall Street debut to find a biotech or pharma company. read more By Max Bayer Biotechs do not have the arsenal of antibiotic hopefuls in their pipelines to match the growing threat of antimicrobial resistance, according to a new BIO report published Monday. read more By Angus Liu With a growing ambition to become a global mRNA enterprise, Moderna has found a way to spend the huge windfall from selling COVID-19 vaccines: a geographic expansion into Asia. read more By Andrea Park While many companies developing blood tests and genomic analyses for cancer are aiming to improve early diagnosis, most of Veracyte’s tests focus instead on what comes after. read more Resources 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: Blue Matter What’s in store for the CNS therapeutics market in 2022? This paper looks ahead in Alzheimer’s, Parkinson’s, DMD, psychiatric disorders, pain, and more. 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. 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