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888 News Found

Moderna sues Pfizer, BioNTech for mRNA patent infringement
News | August 28, 2022

Moderna sues Pfizer, BioNTech for mRNA patent infringement

Complaints to be filed in both United States and Germany alleging that Pfizer and BioNTech's COVID-19 vaccine Comirnaty unlawfully infringes patents Moderna filed between 2010 and 2016


Novartis to spin-off Sandoz business to a standalone company
News | August 28, 2022

Novartis to spin-off Sandoz business to a standalone company

Sandoz is planned to be incorporated in Switzerland and to be listed on the SIX Swiss Exchange, with an American Depositary Receipt (ADR) program in the US


Cipla receives 6 observations from USFDA for Goa facility
Drug Approval | August 28, 2022

Cipla receives 6 observations from USFDA for Goa facility

There are no data integrity (DI) observations.


Lupin launches Desvenlafaxine extended-release tablets in the US
News | August 27, 2022

Lupin launches Desvenlafaxine extended-release tablets in the US

Desvenlafaxine Extended-Release Tablets, 25 mg is a generic equivalent of Pristiq Extended-Release Tablets, 25 mg of PF PRISM C.V.


US FDA inspection at Gland Pharma's Dundigal facility, Hyderabad
News | August 26, 2022

US FDA inspection at Gland Pharma's Dundigal facility, Hyderabad

The company has received 1 (ONE) observation on Form 483 with respect to ANDA filed for the product to be manufactured at the said Facility.


Olaparib approved in Japan as adjuvant treatment for patients with high recurrent risk breast cancer
Drug Approval | August 26, 2022

Olaparib approved in Japan as adjuvant treatment for patients with high recurrent risk breast cancer

First and only PARP inhibitor to improve invasive disease-free survival, the primary endpoint, and overall survival, a key secondary endpoint of the OlympiA trial, in these patients


Lupin receives approval from US FDA for Formoterol Fumarate Inhalation Solution
Drug Approval | August 25, 2022

Lupin receives approval from US FDA for Formoterol Fumarate Inhalation Solution

Formoterol Fumarate Inhalation Solution (RLD Perforomist) had estimated annual sales of US $282 million in the US


Merck gets fast track designation from the USFDA for anticoagulant therapy
Drug Approval | August 24, 2022

Merck gets fast track designation from the USFDA for anticoagulant therapy

Phase 2 Study of MK-2060 Currently Ongoing in People with End-Stage Renal Disease Receiving Hemodialysis


Unichem Laboratories receives ANDA approval for Carbamazepine Tablets
Drug Approval | August 24, 2022

Unichem Laboratories receives ANDA approval for Carbamazepine Tablets

Carbamazepine Tablets are indicated for use as an anticonvulsant drug and in the treatment of the pain associated with true trigeminal neuralgia


Wockhardt signs USFDA approved manufacturing partners
Drug Approval | August 22, 2022

Wockhardt signs USFDA approved manufacturing partners

The company is relieving all its staff who were directly engaged by our US subsidiary in its plant in connection with the manufacturing process in a phased manner