Industry News

The International Society for Pharmaceutical Engineering (ISPE) ISPE announced the release of their latest Guide, ISPE Good Practice Guide: Technology Transfer 3rd Edition. This Guide provides industry good practices for successful and efficient execution of technology transfer projects.

INDIAN DRUG majors Lupin, Sun Pharma and Glenmark Pharmaceuticals are recalling various drugs from the US market for a variety of reasons.

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A new study in rodents has shown that the brain’s cerebellum—known to play a role in motor coordination—also helps control the brain’s reward circuitry. Researchers found a direct neural connection from the cerebellum to the ventral tegmental area (VTA) of the brain, which is an area long known to been involved in reward processing and encoding. These findings, published in Science, demonstrate for the first time that the brain’s cerebellum plays a role in controlling reward and social preference behavior, and sheds new light on the brain circuits critical to the affective and social dysfunction seen across multiple psychiatric disorders. The research was funded by the National Institute of Mental Health (NIMH), part of the National Institutes of Health.

The Federation of Indian Chambers of Commerce and Industry (FICCI) has welcomed the Government's announcement of according 'industry status' to private hospitals, along with support for land acquisition, clearances and funding, to boost expansion of healthcare infrastructure in tier 2 and 3 cities.

The U.S. Food and Drug Administration approved the first generic version of Sabril (vigabatrin) 500 mg tablets for treating complex partial seizures, also called focal seizures, as an adjunctive therapy (given with another primary treatment) in patients 10 years and older who have responded inadequately to several alternative (refractory) treatments.

In recent years, an overwhelming body of clinical evidence has firmly established the HIV Undetectable = Untransmittable (U=U) concept as scientifically sound, say officials from the National Institutes of Health. U=U means that people living with HIV who achieve and maintain an undetectable viral load—the amount of HIV in the blood—by taking and adhering to antiretroviral therapy (ART) as prescribed cannot sexually transmit the virus to others.

A research team led by investigators from the National Institutes of Health and Global Good has developed a computer algorithm that can analyze digital images of a woman’s cervix and accurately identify precancerous changes that require medical attention. This artificial intelligence (AI) approach, called automated visual evaluation, has the potential to revolutionize cervical cancer screening, particularly in low-resource settings.

Eli Lilly and Company and Loxo Oncology, Inc. announced a definitive agreement for Lilly to acquire Loxo Oncology for $235.00 per share in cash, or approximately $8.0 billion. Loxo Oncology is a biopharmaceutical company focused on the development and commercialization of highly selective medicines for patients with genomically defined cancers. 

A global resource that includes data on thousands of inherited variants in the BRCA1and BRCA2 genes is available to the public. The BRCA Exchange was created through the BRCA Challenge, a long-term demonstration project initiated by the Global Alliance for Genomics and Health (GA4GH) to enhance sharing of BRCA1 and BRCA2 data. The resource, available through a website and a new smartphone app, allows clinicians to review expert classifications of variants in these major cancer predisposition genes as part of their individual assessment of complex questions related to cancer prevention, screening, and intervention for high-risk patients.

Lupin Pharmaceuticals, Inc. is voluntarily recalling 5 lots of Ceftriaxone for Injection, USP, 250mg, 10 lots of Ceftriaxone for Injection, USP, 500mg, 24 lots of Ceftriaxone for Injection, USP, 1g and 3 lots of Ceftriaxone for Injection, USP 2g, to the hospital/physician level. The products have been found to contain visual grey particulate matter in reconstituted vials.