Industry News

- Read more about GenVec announces US FDA lifts clinical hold on phase 1/2 trial of CGF166
GenVec, Inc., a clinical-stage gene delivery company, announced that it was notified by its collaborator, Novartis, that the Food and Drug Administration (FDA) has lifted the clinical hold on the phase 1/2 clinical trial of CGF166 in patients with severe to profound hearing loss.
- Read more about AbbVie, BMS collaborate to Evaluate the Rova-T plus Opdivo and Opdivo + Yervoy Regimen
AbbVie and Bristol-Myers Squibb Company announced a clinical trial collaboration to evaluate the safety, tolerability and efficacy of AbbVie's investigational biomarker-specific antibody drug conjugate Rova-T (rovalpituzumab tesirine) in combination with Bristol-Myers Squibb's Opdivo (nivolumab) and Opdivo + Yervoy (ipilimumab) regimen as a treatment for relapsed extensive-stage small cell lung cancer (SCLC).
- Read more about Allergan Receives Positive Opinion For Truberzi from CHMP
Allergan plc, a leading global pharmaceutical company, announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a Positive Opinion for TRUBERZI (eluxadoline) in the European Union. TRUBERZI is an oral medication that relieves the main symptoms of irritable bowel syndrome with diarrhoea (IBS-D) in adults. In two pivotal trials, TRUBERZI significantly reduced two of the most bothersome symptoms of IBS-D, abdominal pain and diarrhoea, with sustained relief demonstrated over six months. TRUBERZI was generally well tolerated with the most common side effects being nausea, constipation, and abdominal pain.
- Read more about Merck’s Investigational Ebola Zaire Vaccine Receives Breakthrough Therapy Designation from FDA and PRIME Status from EMA
Merck, known as MSD outside the United States and Canada, announced two regulatory milestones for the company’s investigational vaccine for Ebola Zaire, V920 (rVSV∆G-ZEBOV-GP, live attenuated): the U.S. Food and Drug Administration (FDA) has granted the vaccine candidate Breakthrough Therapy Designation, and the European Medicines Agency (EMA) has granted PRIME (PRIority MEdicines) status.
- Read more about Shire’s ONIVYDE Receives Positive CHMP Opinion
Shire plc announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the marketing authorization for the use of ONIVYDE® (irinotecan pegylated liposomal formulation) also known as nal-IRI or MM-398, for the treatment of metastatic adenocarcinoma of the pancreas, in combination with 5-fluorouracil (5-FU) and leucovorin (LV), in adult patients who have progressed following gemcitabine based therapy.

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- Read more about Gilead’s Type II Variation Application for Truvada Receive Positive Opinion by European CHMP
Gilead Sciences, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Type II variation application for once-daily Truvada^®(emtricitabine 200 mg/tenofovir disoproxil 245 mg) in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 infection among uninfected adults at high risk, a strategy known as pre-exposure prophylaxis, or PrEP. Truvada was approved by the EMA in 2005 for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults, and is currently the most prescribed antiretroviral medicine in Europe as part of combination therapy.
- Read more about AstraZeneca’s antibiotic Zavicefta show positive results in Phase III trial
AstraZeneca announced positive results from the Phase III REPROVE trial for Zavicefta (ceftazidime-avibactam), a new combination antibiotic for the treatment of a broad range of serious Gram-negative bacterial infections in hospitalised patients. Zavicefta has been developed in response to the urgent need for new antibiotics to treat serious infections that are becoming increasingly resistant to current antibiotics commonly used for serious infections, such as carbapenems and polymixins, including colistin.

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- Read more about AstraZeneca receives approval in the EU for Qtern for Type 2 diabetes patients
AstraZeneca announced that the European Commission (EC) has approved Qtern (saxagliptin/dapagliflozin) tablets for the treatment of type 2 diabetes in all 28 EU member countries plus Iceland, Liechtenstein and Norway. The fixed-dose combination of saxagliptin and dapagliflozin is the first DPP-4i/SGLT-2i combination product to be approved in Europe.
- Read more about Amgen, UCB submit BLA for romosozumab to US FDA
Amgen and UCB announced the submission of a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for romosozumab, an investigational monoclonal antibody for the treatment of osteoporosis in postmenopausal women at increased risk of fracture. Romosozumab works by binding and inhibiting sclerostin, a protein naturally occurring in the bone, thereby increasing bone formation and decreasing bone resorption.
- Read more about Inclusion of coronary stent in NLEM is weakening the industry sentiment: FICCI
As the Indian medical device industry braces up for new opportunities, it remains tied up in the restrictive business environment. With the recent announcement on inclusion of coronary stent of all categories in National List of Essential Medicine the industry sentiment has further weakened.