Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) today announced that the U.S. Food and Drug Administration ("FDA") has granted approval for the Company's Abbreviated New Drug Application ("ANDA") for Albuterol Sulfate Inhalation Aerosol, previously known as AMP-008. This product is for the treatment or prevention of bronchospasm in patients four years of age and older with reversible obstructive airway disease and the prevention of exercise-induced bronchospasm in patients four years of age and older. The FDA determined that Amphastar's albuterol is bioequivalent and therapeutically equivalent to Teva Respiratory LLC's ProAir® HFA (albuterol sulfate) Inhalation Aerosol.
Wednesday, May 22, 2024
G1, Deimos in Global (Excluding Asia-Pacific) License Agreement
Jupiter Bioventures will Gain Exclusive Rights for the Clinical Development, Regulatory Submissions, and Commercialization of Lerociclib for Radioprotection in the US, Europe, Japan, and All Other Global Markets Excluding Asia-Pacific
G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, and Deimos Biosciences, a portfolio company of Jupiter Bioventures, announced a global licensing agreement (excluding the Asia-Pacific region) for lerociclib for radioprotective uses. Lerociclib is a potent and selective inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6). Such inhibitors can increase the survival of animals exposed to radiation.
Jupiter Bioventures is a company creation engine that focuses on de-risking early-stage projects, partnering with the world’s leading biologists and physicians.
Novo Nordisk Hit by Second Fire in a Week
Emergency crews are fighting a fire at a Novo Nordisk facility for the second time in a week.
The Danish pharmaceutical giant said Wednesday that a blaze started outside a building at its headquarters in the Copenhagen suburb of Bagsvaerd, and has spread to an adjacent office building.
"The fire brigade is present, and the process of extinguishing the fire is expected to last some hours," the company said.
The smoke isn't toxic, and there are no reports of injuries, it added.
A building at one of the company's other sites was also hit by fire last Thursday. That blaze broke out on the roof of a new building under construction at a manufacturing site in Kalundborg, a city west of the capital Copenhagen, where the drug maker is expanding capacity for its popular diabetes and weight-loss drugs.
Biogen in up to $1.8 billion deal as rare diseases take center stage
Biogen said on Wednesday it had agreed to buy privately held Human Immunology Biosciences for up to $1.8 billion, bulking up on rare disease medicines as its older multiple sclerosis drugs face tepid demand due to rising competition.
Human Immunology's (HI-Bio) felzartamab has completed mid-stage studies for a type of kidney disease called primary membranous nephropathy, and in patients with a disease where the immune system makes antibodies that damage their transplanted organ.
The San Francisco-based company is also testing the therapy in patients with another chronic kidney disease known as IgA nephropathy. The therapy developer plans to conduct late-stage trials.
Since Christopher Viehbacher took the helm in late 2022, Biogen has acquired rare disease drugmaker Reata for $6.5 billion, abandoned its controversial Alzheimer's disease drug Aduhelm and cut jobs.
The company is now counting on newer medicines such as a second approved Alzheimer's drug Leqembi, developed with Japanese partner Eisai, as well as Reata's Skyclarys to help drive growth.
The deal consists of $1.15 billion in upfront and up to $650 million in potential payments if felzartamab achieves certain development milestones.
The deal is expected to close in the third quarter, the companies said on Wednesday. HI-Bio is backed by investors such as biotech-focused ARCH Venture Partners and Monograph Capital.
https://finance.yahoo.com/news/biogen-buy-human-immunology-biosciences-113755099.html
Tuesday, May 21, 2024
Roundhill Investments Launches GLP-1 & Weight Loss ETF (OZEM)
OZEM provides exposure to the rapidly growing weight loss management market, which is expected to reach $100 billion by 2030.
Roundhill Investments, an ETF sponsor focused on innovative financial products, is pleased to announce the launch of the Roundhill GLP-1 & Weight Loss ETF (OZEM), which began trading on Nasdaq today. OZEM is the world's first ETF focused exclusively on the rapidly growing sector of GLP-1 receptor agonists and other weight management drugs.
"OZEM offers investors a unique opportunity to efficiently access the companies leading the charge against the global obesity epidemic," said Dave Mazza, CEO of Roundhill Investments. "With obesity rates nearly tripling since 1975 and projected to affect over half the population by 2035, the market for weight loss drugs is in its early stages, offering substantial growth potential for companies pioneering innovation in the space."
The obesity treatment market is set for explosive growth. Goldman Sachs Research forecasts that the market could expand by more than 16 times its current size to reach $100 billion by 2030.2
The Roundhill GLP-1 & Weight Loss ETF (OZEM) is an actively-managed ETF that is designed to provide exposure to a global portfolio of companies involved in developing weight loss therapeutics.
The fund's top holdings include:
HOLDINGS | % WEIGHTING |
Eli Lilly & Co | 20.16 % |
Novo Nordisk A/S | 19.90 % |
Innovent Biologics Inc | 4.59 % |
Zealand Pharma A/S | 4.57 % |
Chugai Pharmaceutical Co Ltd | 4.47 % |
Amgen Inc | 4.24 % |
Altimmune Inc | 4.19 % |
Viking Therapeutics Inc | 3.50 % |
Terns Pharmaceuticals Inc | 3.41 % |
Structure Therapeutics Inc | 3.24 % |
Holdings are subject to change. Data as of 5/20/24.
1 WHO, Global Health Observatory (2022), Ourworldindata.com, 2 Goldman Sachs Global Investment Research; Company data.
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