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Delhi HC grants 10 days’ time to Govt to file counter affidavit on petitions against ban of 14 FDCs

AuroBlog - Aurous Healthcare Clinical Trials blog

The Delhi High Court has granted ten days’ time to the Government of India and the nation’s drug regulator to file a counter affidavit on the petitions filed by almost 28 pharma companies against the order prohibiting manufacturing, distribution and sale of 14 FDCs licensed prior to the year 1988, in the beginning of June. […]

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Is License Compulsory For Starting Pharmaceutical Business In India?

Fossil Remedies

When you launch a PCD pharma company , you have to do several preparations. In a pharma business, you have a distribution network like a pharma manufacturing company, pharma marketing company, C&F agents, wholesalers/distributors/stockiest, retailers, and pharmacies. Wholesale Drug License.

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physIQ licenses virtual trial tech to Janssen in multi-year deal

pharmaphorum

Biosensor firm physIQ has licensed its technology to Johnson & Johnson’s Janssen pharma unit in a multi-year deal, to investigate use of wearable sensors in virtual clinical trials. The pharma company will use the technology known as accelerateIQ to collect data across its clinical studies through a variety of wearable biosensors.

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How the patient voice is becoming vital for drug approval

pharmaphorum

Rebecca Sanders from Lipodystrophy UK tells us how the patient voice helped convince NICE to approve a much-needed drug for this rare disease, and explores how regulators and pharma companies can help make patient involvement in HTA more impactful. Read below for a preview! .

Drugs 99
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Novartis taps immuno-oncology partner BeiGene for TIGIT drug

pharmaphorum

Novartis has joined the ranks of big pharma companies developing TIGIT-targeted drugs for cancer, and found its candidate in an existing partner, Chinese biotech BeiGene. Pharma companies are looking at whether blocking TIGIT as well as PD-1/PD-L1 can improve the efficacy of cancer immunotherapy.

Drugs 96
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In the News: October Regulatory and Development Updates

Camargo

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely.

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Angelini and Arvelle create neurology player with $960m merger

pharmaphorum

There’s a new player in the neurology and mental health drugs market after Italy’s Angelini Pharma merged with Switzerland’s Arvelle Therapeutics in a deal worth up to $960 million based around the anti-seizure drug cenobamate. It is already in the late stages of development and expected to be approved in Europe later this year.