The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
Gilead Sciences plans to launch in the US authorized generic versions of its two top-selling treatments for chronic hepatitis C virus (HCV), Epclusa (sofosbuvir 400 mg/velpatasvir 100 mg) and Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg), through a...
Allergan plans to open its first Medical Aesthetics Innovation Center in Chengdu, China in early 2019. The center will have a training center for medical aesthetics healthcare professionals as well as an education and product experience center for...
Almirall (ALM), a Barcelona-based provider of medicines and medical devices, has closed a deal to acquire a portfolio of five products from Allergan's US Medical Dermatology unit for approximately $550 million. The deal also involves a possible...
Novo Nordisk has announced plans to restructure its research & development (R&D) organization to accelerate expansion and diversification of its pipeline across chronic diseases. To enable this increased biological and technological...
The US Food and Drug Administration (FDA) has taken action to support recovery from Hurricane Florence, particularly to prevent drug shortages from pharmaceutical companies manufacturing important drugs. The hurricane struck North Carolina, South...
The FDA has issued two final guidances and one draft guidance for implementing the Drug Supply Chain Security Act (DSCSA), a law that specifies requirements for building an electronic, interoperable system to identify and trace certain prescription...
The FDA has found an additional impurity in its ongoing investigation of several recently recalled drug products containing the active pharmaceutical ingredient (API) valsartan, used to treat high blood pressure and heart failure. The investigation...
The US Food and Drug Administration (FDA) has approved a new drug application (NDA) for Xelprostm (latanoprost ophthalmic emulsion) 0.005%, an eye-pressure reducer, from Sun Pharmaceutical Industries, a Mumbai, India-headquartered pharmaceutical...
Allergan has agreed to acquire Bonti, a Newport Beach, California-based clinical-stage biopharmaceutical company focused on developing and commercializing fast-acting neurotoxin programs for aesthetic and therapeutic applications.
Following...
The US Senate has passed The Opioid Crisis Response Act of 2018, bipartisan legislation that included over 70 proposals from five Senate committees to address the challenge of opioid misuse in the US. The bill, passed in a vote of 99-1, will now...
GlaxoSmithKline (GSK) has invested $36 million to modernize its site in Mississauga, Ontario, Canada into a consumer healthcare and prescription supply site. The investment enabled facility modifications, new equipment purchases, and enhanced...
Sanofi has announced plans to change the organizational structure of two of its global business units (GBUs) to provide greater focus on its operations in mature markets and emerging markets.
The company says it will create a new Primary Care GBU...
Alcon, the eye-care division of Novartis, has announced plans to locate its future global headquarters in the Canton of Geneva, Switzerland, following completion of its proposed spin-off from Novartis.
Alcon's new global headquarters in Geneva...
Regeneron Pharmaceuticals, a Tarrytown, New York-based biopharmaceutical company, plans to invest approximately $800 million over seven years to expand its laboratory space, manufacturing capacity, and warehouse facilities at the company's campus...
Following a business review, GlaxoSmithKline (GSK) has announced staff reductions of up to 650 employees across its US business, primarily in sales and back-office operations.
These changes are part of global restructuring program, announced by...
