FDA revokes emergency use authorization for Eli Lilly's bamlanivimab » 16:4604/1604/16/21
The U.S. FDA revoked the…
The U.S. FDA revoked the emergency use authorization that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients. Based on its ongoing analysis of emerging scientific data, specifically the sustained increase of SARS-CoV-2 viral variants that are resistant to bamlanivimab alone resulting in the increased risk for treatment failure, the FDA has determined that the known and potential benefits of bamlanivimab, when administered alone, no longer outweigh the known and potential risks for its authorized use. Therefore, the agency determined that the criteria for issuance of an authorization are no longer met and has revoked the EUA. Reference Link
Amyris to host conference call » 16:2404/1604/16/21
Management holds an…
Management holds an investor update conference call on April 22 at 1 pm. Webcast Link
Amgen completes acquisition of Five Prime » 08:2604/1604/16/21
Amgen (AMGN) announced…
Amgen (AMGN) announced that it has successfully completed its previously announced tender offer to purchase all outstanding shares of common stock of Five Prime Therapeutics (FPRX) for $38.00 per share in cash. The aggregate consideration to be paid by Amgen to complete the tender offer and the subsequent merger is approximately $1.9B without giving effect to related transaction fees and expenses. Following completion of the merger, Five Prime shares have ceased trading on the Nasdaq Global Select Market.
Twist Bioscience exercises right of first refusal to expand Portland facility » 08:0704/1604/16/21
Twist Bioscience announced that it has exercised its right of first refusal to expand the lease for its "Factory of the Future" manufacturing facility near Portland, Oregon. The expanded lease secures an additional approximately 100,000-square-foot facility within the same building as the approximately 110,000-square-foot facility Twist leases. The expansion allows for Twist to build out additional vertical opportunities including DNA data storage or other high value growth product lines, with Twist's financial commitment beginning in 2022.
Synlogic 10M share Spot Secondary priced at $3.00 » 06:3704/1604/16/21
SVB Leerink acted as sole…
SVB Leerink acted as sole book running manager for the offering.
Eli Lilly requests FDA revoke EUA for bamlanivimab 700 mg alone » 06:3704/1604/16/21
Eli Lilly (LLY) has…
Eli Lilly (LLY) has requested the FDA revoke the Emergency Use Authorization, or EUA, for bamlanivimab 700 mg alone. Lilly made this request due to the evolving variant landscape in the U.S. and the full availability of bamlanivimab and etesevimab together. This request is not due to any new safety concern. This final step in Lilly's transition to only supply bamlanivimab and etesevimab for administration together in the U.S. for the treatment of COVID-19 - as planned with the FDA - follows the modification of contracts with the U.S. government to ensure adequate supply of etesevimab to be used together with bamlanivimab. All sites in the U.S. now have access to obtain doses of etesevimab for administration with bamlanivimab-which together neutralize more of the emerging COVID-19 variants in the U.S. than bamlanivimab alone, including the rapidly growing B.1.427/B.1.429 California strain that currently accounts for 50% of the virus in California and over 10% across a number of additional states. In the U.S., bamlanivimab alone should no longer be administered. However, sites of care should not dispose of bamlanivimab supply; instead, they should order etesevimab to pair with it. Lilly is not requesting the withdrawal of emergency authorization for bamlanivimab alone in any other jurisdiction at this time. However, its use together with etesevimab, where authorized and available, is preferred over bamlanivimab alone. Lilly, in collaboration with Amgen (AMGN), expects to manufacture sufficient supply of bamlanivimab and etesevimab together to meet global supply needs. Going forward, Lilly will submit only bamlanivimab administered with etesevimab together for authorization globally with a full transition expected by June.
Synlogic announces common stock offering, no amount given » 16:0504/1504/15/21
Synlogic announced that…
Synlogic announced that it has commenced an underwritten public offering of its common stock. SVB Leerink is acting as sole book-running manager for the offering.
Amyris to acquire EcoFabulous Cosmetics, terms not disclosed » 08:0304/1504/15/21
Amyris announced that it…
Amyris announced that it has executed a binding term sheet for the acquisition of Gen Z-focused beauty brand, EcoFabulous Cosmetics. The acquisition furthers Amyris's growth and market leadership in clean beauty and complements Amyris's family of consumer brands, consisting of Biossance, Pipette, Rose Inc., JVN, Terasana, and Costa Brazil. Amyris is acquiring a 70% controlling interest in EcoFabulous and expects to grow the Gen Z consumer segment through Amyris's innovative science, sustainable ingredients, clean formulation and direct-to-consumer marketing expertise. Marissa will join Amyris to lead brand innovation and be the Chief Creative Officer for the EcoFabulous brand.
PTC Therapeutics announces FIREFISH trial results at AAN virtual meeting » 05:2504/1504/15/21
PTC Therapeutics (PTCT)…
PTC Therapeutics (PTCT) announced that results from Part 2 of the pivotal FIREFISH trial demonstrated that infants with type 1 spinal muscular atrophy, or SMA, treated with Evrysdi obtained increases in survival and sustained improvements in achieving key motor milestones, including head control, sitting, rolling over, and further developing towards acquiring the ability to stand, and walk. Data were presented at the 2021 American Academy of Neurology, or AAN, virtual annual meeting. Data from Part 2 of the FIREFISH trial demonstrated that at 24 months of treatment, 93% of infants were alive and 83% were alive without permanent ventilation. There were no new deaths between months 12 and 24. Importantly, infants treated with Evrysdi maintained the ability to feed orally 92% at month 24. Further exploratory data suggests similar maintenance in ability to swallow 95%. In the natural course of the disease, infants with type 1 SMA older than 12 months generally require feeding support. In addition, fewer hospitalizations were observed during the second year of treatment with Evrysdi compared with the natural course of the disease, with 34% not requiring hospitalization during 24 months of treatment. Evrysdi is designed to treat SMA by increasing and sustaining the production of the SMN protein, which is found throughout the body and is critical for maintaining healthy motor neurons and movement. Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics. Evrysdi is marketed in the United States by Genentech, a member of the Roche (RHHBY).
Medavail says North Texas health system expands technology agreement » 16:0604/1404/14/21
MedAvail Holdings announced that a health system in North Texas has expanded its technology agreement with MedAvail, and has deployed MedAvail's MedCenter technology at 16 emergency and urgent care sites in Texas. Patients visiting these urgent and emergency care sites are able to consult virtually with a system pharmacist and fill their prescriptions at the point of care through the MedCenter, eliminating the need to make a separate trip to a pharmacy. Through MedAvail's Pharmacy Technology segment, the company is able to enhance pharmacy services offered by healthcare providers and retail chains. Enterprise customers can purchase MedAvail's technology in order to provide these solutions under their own brands. "We are proud to offer our software and MedCenter technology to large healthcare systems focused on medication adherence and patient satisfaction," said Dave Rawlins, Chief Commercial Officer at MedAvail. "Quick and convenient access to care is even more critical now than ever. MedAvail's innovative pharmacy technology is adaptable to a number of different environments, enabling our partners to improve ease of medication access without compromising safety."