Industry News

Allergan plc, announced that the company has received approval from the U.S. Food and Drug Administration (FDA) to market JUVÉDERM VOLBELLA® XC, for use in the lips for lip augmentation and for correction of perioral rhytids, commonly referred to as perioral lines, in adults over the age of 21.

Janssen-Cilag International NV announced that the European Commission (EC) has approved the use of TREVICTA® (paliperidone palmitate a 3 monthly injection) for the maintenance treatment of schizophrenia in adult patients. TREVICTA will provide the longest dosing interval available for an antipsychotic medication in the European Union, allowing patients to maintain an optimal level of treatment in their blood with fewer administrations, compared to currently available antipsychotic treatments. This may improve outcomes for patients, carers and healthcare professionals. TREVICTA is indicated for the maintenance treatment of schizophrenia in adult patients who are clinically stable on XEPLION®¬, a 1-monthly paliperidone palmitate product that was approved in 2011 for the maintenance treatment of schizophrenia in the European Union.

Allergan plc, a leading global pharmaceutical company, and Medicines360, a nonprofit women's health pharmaceutical company with a mission of expanding access to quality medicines, announced that they will donate 10,000 units of their hormonal IUD, Liletta (levonorgestrel-releasing intrauterine system) 52 mg, to the CDC Foundation. In addition, Allergan will donate over 40,000 one-month cycle packs of oral contraceptives. The contributions are in response to the outbreak of the Zika virus and are designed to help reduce unintended pregnancies in Puerto Rico, while the risk of the Zika virus is prevalent. Research has shown that pregnant women infected with the Zika virus are at risk of giving birth to infants born with microcephaly, a condition where babies' heads and brains are smaller and may not have developed properly during pregnancy.

Strides Shasun Limited has received the first to file tentative approval from the United States Food & Drug Administration (USFDA) for Roflumilast tablets, 500 mcg. The product received approval in 15 months under the new the Generic Drug User Fee Amendments of 2012 (GDUFA) goal date regime. The product can be launched earliest by January 2020.

According to the Confederation of Indian Industries ( CII),  Currently valued at around $ 4.6 billion ( at current forex rate of Rs. 67 per $, 30800 Crore.), the beauty and cosmetic industry is projected to grow between 18-20 per cent per annum in the next couple of years. There are many global giant players like Procter and Gamble, Loreal, Unilever etc. which have strong presence in Indian market. Apart from these MNC companies, many Indian companies like Himalaya , Godrej, ITC,  Emami, Marico, Dabur etc.

BioVentrix Inc., an emerging medical device company for less invasive treatment of heart failure (HF), announced that it has received a US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval to initiate its pivotal clinical trial, named ALIVE (American Less Invasive Ventricular Enhancement). The trial is designed to demonstrate the safety and effectiveness of the Revivent TC TransCatheter; a hybrid closed-chest transcatheter procedure to treat patients suffering from ischemic cardiomyopathy by reshaping and restoring the left ventricle (LV).  This is accomplished by implanting micro-anchoring pairs in the LV to exclude scarred myocardium from the healthy tissue.

Dr Reddy’s Laboratories, a Rs.15,800 crore plus second largest pharma company in India, announced that its US subsidiary, Promius Pharma, LLC, U.S., launched Sernivo (betamethasone dipropionate) spray, 0.05% in the US. Sernivo spray, a prescription topical steroid approved by the Food and Drug Administration (FDA) in February of 2016, is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older.

Jazz Pharmaceuticals plc, an international biopharmaceutical company, and Celator Pharmaceuticals, Inc., an oncology-focused biopharmaceutical company, have entered into a definitive agreement for Jazz Pharmaceuticals to acquire Celator for $30.25 per share in cash, or approximately $1.5 billion.

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Teva Pharmaceutical Industries Ltd. announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for SD-809 (deutetrabenazine) tablets for the treatment of chorea associated Huntington disease (HD). This is the first deuterated product to be reviewed by the FDA. The FDA has asked Teva to examine blood levels of certain metabolites. These metabolites are not novel, and are the same seen in subjects who take tetrabenazine or deutetrabenazine. No new clinical trials have been requested.

Indivior Inc., a subsidiary of Indivior PLC announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for RBP-6000 buprenorphine monthly depot, an investigational new drug for the treatment of opioid use disorder as part of a complete treatment plan to include counseling and psychosocial support.