Industry News

Claris Lifesciences Limited has received the Abbreviated New Drug Application (ANDA) approval for bupivacaine hydrochloride in 8.25% dextrose injection USP, 7.5 mg/ml, single-dose ampules with 2ml fill volumes, in the United States of America (US).

Faron Pharmaceuticals Ltd, a clinical stage biopharmaceutical company, and Abzena plc, a life sciences group providing services and technologies to enable development and manufacture of biopharmaceutical products, announce that they have entered into an agreement whereby Abzena will manufacture Clevegen®, a novel therapeutic antibody being developed by Faron to reduce immune suppression in cancer. Clevegen may also have the potential to be used in other situations where there is an inadequate immune response, such as in chronic infections or during vaccination.

Evoke Pharma, Inc., a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, announced that the US Food and Drug Administration (FDA) has conditionally accepted the proprietary brand name, "Gimoti," for the Company's product candidate, EVK-001 (metoclopramide nasal spray). A request for proprietary name review for Gimoti will be included if and when Evoke submits a New Drug Application (NDA) for the product candidate.

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.

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).

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.

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.

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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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.

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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