Page 19 - Pharmaceutical
US FDA completes inspection of Strides Shasun's Bangalore facility
The company says the inspection was completed without issuance of Form 483, which is issued by US FDA for violations of good manufacturing practices
 "US FDA completes inspection of Strides Shasun's Bangalore facility")
Sanofi, Boehringer Ingelheim ink animal health-consumer healthcare business swap pact
While Boehringer Ingelheim will transfer its CHC business to Sanofi, in return it will get Sanofi's animal health business Merial. In addition, Boehringer Ingelheim will pay Sanofi Euro 4.7 bn
 "Sanofi, Boehringer Ingelheim ink animal health-consumer healthcare business swap pact")
RPG Life Sciences ties up Italian firm to foray into cosmetics
Through the tie-up with Labo Cosprophar, the Mumbai-based pharmaceutical company will launch two new products for hair and skin care
 "RPG Life Sciences ties up Italian firm to foray into cosmetics")
Impact of Brexit to be majorly on drug and medical device regulation: Report
The European Medicines Agency (EMA), which is headquartered in the UK, is likely to be swiftly relocated to the EU, says GlobalData in a whitepaper
 "Impact of Brexit to be majorly on drug and medical device regulation: Report")
DCGI grants permission for India's first siRNA drug trial
Biocon and the US-based Quark to start phase II/III study of a novel siRNA (small interfering RNA) drug candidate (QPI-1007) in rare eye disease in India
 "DCGI grants permission for India's first siRNA drug trial")
Lupin receives US FDA nod for generic Activella tablet
Tablet is indicated in a woman with a uterus for treatment of moderate to severe vasomotor symptoms due to menopause and prevention of postmenopausal osteoporosis
Introduce data protection as an IPR: Study
The Assocham-TechSci Research study also suggested for digitisation of IPR for pharmaceuticals in India to strengthen online processing
 "Introduce data protection as an IPR: Study")
Cipla and Russia's Nacimbio join hands for HIV and hepatitis C drugs
As per the agreement, two sides will collaborate to set up a facility in Russia for the production of antiretroviral drugs
 "Cipla and Russia's Nacimbio join hands for HIV and hepatitis C drugs")
Zydus Cadila partners with Eczacibasi to tap Turkish biosimilar market
As per the deal, Zydus will market biosimilars, which are currently unavailable in Turkey especially for the treatment of cancer
 "Zydus Cadila partners with Eczacibasi to tap Turkish biosimilar market")
US specialty pharma firms to change their M&A strategies: Moody's
The slowdown in acquisitions, along with the scrutiny on aggressive price increases, will force many specialty pharmaceutical companies to shift their growth strategies, says the ratings agency
 "US specialty pharma firms to change their M&A strategies: Moody's")
Gelatine capsules technically better than HPMC, says PHD Chamber to DCGI
The current annual installed capacity of HPMC is around 2 billion compared to gelatine's 120 billion, hence replacing HPMC with gelatine is not a feasible option
 "Gelatine capsules technically better than HPMC, says PHD Chamber to DCGI")
Chaturbhuj Pharmaceutical to commercialise ayurvedic diabetes drug
The company has signed licensing agreement with National Research Development Corporation (NRDC) for Ayush-82, developed by Central Council for Research in Ayurvedic Sciences
 "Chaturbhuj Pharmaceutical to commercialise ayurvedic diabetes drug")
Teva, Allergan agree to sell 8 products to Dr Reddy's for $350 mn
The acquired portfolio consists of products that are being divested by Teva as a precondition to its closing of the acquisition of Allergan's generics business
 "Teva, Allergan agree to sell 8 products to Dr Reddy's for $350 mn")
Sun Pharma's OTC business forays into dermatology
The business, which current markets dietary supplements, analgesics and antacids, has rolled out Suncros, a sunscreen product
Zydus Cadila to start phase 2 trials of saroglitazar for liver disease
The company has received US FDA approval to initiate phase 2 clinical trials of saroglitazar in patients with non-alcoholic steatohepatitis (NASH), a liver disease, in the US
Eisai and Novartis to co-promote anticancer drugs in US
Two companies will promote Eisai's anticancer agent Lenvima in combination with everolimus as treatment for advanced renal cell carcinoma in the US
Lupin receives US FDA's nod for antifungal drug voriconazole
The company has received approval for voriconazole tablet (50 mg & 200 mg) and oral suspension (40 mg/mL) - generic versions of PF Prism CV's Vfend tablet and oral suspension
 "Lupin receives US FDA's nod for antifungal drug voriconazole")
Frontida BioPharm buys Sun Pharma's two US facilities
Sun Pharma has sold its two oral solid dosage manufacturing facilities located at Philadelphia and Aurora, along with 15 related products, to Frontida BioPharm
 "Frontida BioPharm buys Sun Pharma's two US facilities")
Dr Reddy's launches psoriasis drug Sernivo in US
Sernivo (betamethasone dipropionate) spray is used for the treatment of mild to moderate plaque psoriasis
Jubilant Biosys inks license pact with US-based Checkpoint for cancer drug
As per the deal, Jubilant Biosys will receive an upfront payment of $ 2 mn and contingent preclinical, clinical and regulatory payments including commercial milestones totalling up to $ 180 mn
 "Jubilant Biosys inks license pact with US-based Checkpoint for cancer drug")
