Industry News

Cempra, Inc. announced that the company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) relating to the company's new drug applications (NDAs) for oral and intravenous solithromycin for the treatment of community-acquired bacterial pneumonia (CABP) in adults.

Achillion Pharmaceuticals, Inc. announced that it has received a $15 million milestone payment from Janssen Research & Development, LLC., part of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), related to enrollment in the OMEGA-1 phase 2b global, clinical trial of JNJ-4178, a 3DAA combination of odalasvir, simeprevir, and AL-335 in patients with treatment-naive chronic hepatitis C virus infection (HCV) without cirrhosis.

Zydus Cadila, an innovation-driven global pharmaceutical company announced that its wholly owned subsidiary company Zydus Healthcare Limited (“Zydus”) has acquired six brands from MSD and its subsidiaries. The brands are DECA-DURABOLIN, DURABOLIN, SUSTANON, MULTILOAD, SICASTAT and AXETEN range, which fall in the men’s health, women’s health, wound management and cardiovascular therapy segments, respectively.

Mylan NV announced the US launch of ethynodiol diacetate and ethinyl estradiol tablets USP, 1 mg / 0.05 mg. Mylan's product was determined to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug, Zovia 1/50E-28 Tablets (Watson).

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Mylan and Biocon have announced that the results of the Heritage study have been published in the Journal of the American Medical Association (JAMA). Study results confirm the efficacy, safety and immunogenicity of MYL-1401O, the proposed biosimilar trastuzumab co-developed by Mylan and Biocon, in comparison to branded trastuzumab.

MiMedx Group, Inc., the leading regenerative medicine company utilizing human amniotic tissue and patent-protected processes to develop and market advanced products and therapies for the wound care, surgical, orthopedic, spine, sports medicine, ophthalmic, and dental sectors of healthcare, announced that the company's EpiFix product has received coverage from insurer Aetna Inc. effective December 23, 2016.

Taro Pharmaceutical Industries Ltd. announced the sale of US rights to Keveyis (dichlorphenamide) to Strongbridge Biopharma plc (Strongbridge), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet need. Keveyis was approved by the US Food and Drug Administration (the FDA) in August 2015 to treat primary hyperkalemic and hypokalemic periodic paralysis, a group of rare hereditary disorders that cause episodes of muscle weakness or paralysis. Keveyis has orphan designation status through August 2022.

Seattle Genetics, Inc. announced that it has received notice from the U.S. Food and Drug Administration (FDA) that a clinical hold or partial clinical hold has been placed on several early stage trials of vadastuximab talirine (SGN-CD33A) in acute myeloid leukemia (AML). The clinical holds were initiated to evaluate the potential risk of hepatotoxicity in patients who were treated with SGN-CD33A and received allogeneic stem cell transplant either before or after treatment. Six patients have been identified with hepatotoxicity, including several cases of veno-occlusive disease, with four fatal events. Overall, more than 300 patients have been treated with SGN-CD33A in clinical trials across multiple treatment settings. Seattle Genetics is working diligently with the FDA to determine whether there is any association between hepatotoxicity and treatment with SGN-CD33A, to promptly identify appropriate protocol amendments for patient safety and to enable continuation of these trials.

Ligand Pharmaceuticals Incorporated, a biopharmaceutical company, has entered into a worldwide license agreement with Ono Pharmaceutical CoL, ltd. Under the license, Ono will be able to use the OmniRat, OmniMouse and OmniFlic platforms to discover fully human mono- and bispecific antibodies.  Ligand is eligible to receive annual platform access payments, development milestone payments and royalties for each product incorporating an OmniAb antibody. Ono will be responsible for all costs related to the programmes.

Pfizer Inc. announced that it has completed the acquisition of the development and commercialization rights to AstraZeneca’s late-stage small molecule anti-infective business, primarily outside the United States. The agreement includes the commercialization and development rights to the newly approved EU drug Zavicefta (ceftazidime-avibactam), the marketed agents Merrem/Meronem (meropenem) and Zinforo (ceftaroline fosamil), and the clinical development assets aztreonam-avibactam (ATM-AVI) and CXL. Zavicefta specifically addresses certain multi-drug resistant Gram-negative infections, including those resistant to carbapenem antibiotics, one of the most significant unmet medical needs in bacterial infections treated with hospital anti-infectives.