LYRICA (pregabalin) Oral Solution CV Phase 3 Trial in Pediatric Epilepsy Meets Primary Endpoint

Pfizer announced positive top-line results of a Phase 3 study examining the use of LYRICA (pregabalin) Oral Solution CV as adjunctive therapy for partial onset seizures in pediatric epilepsy patients one month to less than four years of age. Results showed that adjunctive treatment with LYRICA 14 mg/kg/day resulted in a statistically significant reduction in seizure frequency versus placebo, the primary efficacy endpoint. Treatment with LYRICA at the lower dose (7 mg/kg/day) did not result in a statistically significant…

TEDOR Pharma Announces Recapitalization and New Management

TEDOR Pharma announced the closing of a recapitalization and reorganization of its business, funded by investments from DORA Ventures, Inc. DORA Ventures is a newly formed investment vehicle, owned and controlled by Laura Iorio, Chairwoman of TEDOR Pharma, and Doug Drysdale, President and CEO of TEDOR Pharma. Iorio has served as Chairwoman of TEDOR Pharma since 2009. Drysdale previously served as Chairman and CEO of Pernix Therapeutics (PTX) and as CEO of Alvogen, Inc. Dora Ventures was created to invest in…

Catalent Biologics And Valerius Biopharma To Collaborate On Manufacture Of Specialty Biosimilars

Catalent Pharma Solutions and Valerius Biopharma AG announced that they are to collaborate on the development and manufacture of Valerius’ biosimilar products. Under the agreement, Catalent Biologics will provide cell line development and support cGMP manufacturing activities from Phase 1 through to commercial stages at its state-of-the-art biologics manufacturing facility in Madison, Wisconsin. The project will utilize Catalent’s proprietary GPEx technology, which creates high-performance, highly stable production…

Novartis and Amgen announce FDA approval of Aimovig (erenumab-aooe)

Novartis announced that the US Food and Drug Administration (FDA) has approved Aimovig (erenumab-aooe) for the preventive treatment of migraine in adults. Aimovig is a novel therapeutic approach as the first and only FDA-approved treatment specifically developed to prevent migraine by blocking the calcitonin gene-related peptide receptor (CGRP-R), which is believed to play a critical role in migraine. Aimovig 70 mg is self-administered once monthly via Amgen's device, the SureClick autoinjector, and does not require a…

Amneal Announces FDA Approval and Launch of Generic Welchol (Colesevelam HCl) Tablets, 625 mg

Amneal Pharmaceuticals announced it has received final U.S. Food and Drug Administration (FDA) approval on its Abbreviated New Drug Application for a generic version of Welchol (colesevelam HCI) tablets, 625 mg. Amneal has immediately initiated commercialization activities for this first-to-market opportunity. "We are pleased to be one of the first companies to receive approval and launch a generic version of Welchol," said Rob Stewart, President and Chief Executive Officer of Amneal. "The immediate launch of this product…

Albireo Enrolls First Patient in Phase 3 PFIC Trial of A4250

Albireo Pharma announced the first patient has been enrolled in PEDFIC-1, a Phase 3 clinical trial of lead product candidate A4250, an ileal bile acid transporter (IBAT) inhibitor being studied for the treatment of patients with progressive familial intrahepatic cholestasis (PFIC). “A PFIC diagnosis for our children was shocking and devastating, and we quickly found out that current treatment options are inadequate,” said Kristen and Michael Busby of New York, parents of two children with PFIC. “We applaud all research in…

BioLamina and Novo Nordisk Partner to Advance Stem Cell Based Therapies for Three Common Medical Conditions

BioLamina and collaborators have partnered with Novo Nordisk A/S (Novo Nordisk), a Danish multinational pharmaceutical company, allowing Novo Nordisk to develop novel stem cell based therapies based on Biolaminins, human recombinant laminin cell culture matrices, developed and produced by BioLamina. Novo Nordisk have announced today that they are increasing their commitment to cell therapies, including areas outside of diabetes. The three cell therapy projects they have licensed are all based on BioLamina technology.…

Emulate and AstraZeneca Form Strategic Agreement to Work Side-by-Side on Organs-on-Chips Technology

Emulate, Inc. has formed a collaborative partnership with AstraZeneca’s Innovative Medicines and Early Development (IMED) Biotech Unit to embed its Organs-on-Chips technology within the laboratories of the IMED Drug Safety organization. As part of the agreement, Emulate plans to co-locate scientists within AstraZeneca’s laboratories. The aim of this agreement is to accelerate the development of Organs-on-Chips technology and testing within the context of a pharmaceutical organization. AstraZeneca began collaborating on…

NIH funds three national cryo-EM service centers and training for new microscopists

The National Institutes of Health is supporting efforts to broaden biomedical scientists’ access to cryo-electron microscopy (cryo-EM), the Nobel Prize-winning (link is external) imaging method that is revolutionizing structural biology. The Transformative High Resolution Cryo-Electron Microscopy program is creating three national cryo-EM service centers to provide access to the technology and is supporting the development of cryo-EM training curricula to build a skilled workforce. The awards are anticipated to total $129.5…

FDA approves first epoetin alfa biosimilar for the treatment of anemia

The U.S. Food and Drug Administration approved Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. Retacrit is also approved for use before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery. “It is important for patients to have access to safe, effective and affordable biological products and we…

Lilly’s Galcanezumab Meets Primary Endpoint in Phase 3 Study

Eli Lilly and Company announced that galcanezumab met its primary endpoint in a Phase 3 study of patients with episodic cluster headache, demonstrating statistically significant differences in the reduction of weekly cluster headache attacks compared to placebo across weeks one to three of the two-month, double-blind treatment period. A statistically significantly greater percentage of patients treated with galcanezumab also achieved at least a 50 percent reduction in weekly cluster headache attacks compared to placebo at…

Cambrex Completes Pilot Plant Expansion at its High Point, NC Facility

Cambrex Corporation announced that it has completed a pilot plant expansion at its High Point, NC facility with the installation and commissioning of a fourth reactor suite, increasing the site’s reactor capacity by around 30%. The new 400 sq. ft. suite includes two 2,000 liter glass lined reactors and a 0.6 sq. m. Hastelloy C22 filter dryer, allowing the manufacture of batch sizes typically 10-100kg under cGMP conditions for clinical phase projects. The High Point site has also completed and implemented an upgrade of…

UCB announces BRIVIACT (brivaracetam) now approved by FDA to treat partial-onset (focal) seizures in pediatric epilepsy patients

UCB announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for the company’s newest anti-epileptic drug (AED) BRIVIACT (brivaracetam) CV oral formulations indicated as monotherapy and adjunctive therapy in the treatment of partial onset (focal) seizures in patients age four years and older. This approval provides clinicians with the convenient option to prescribe BRIVIACT to their pediatric patients as a tablet or oral solution, providing flexible administration…

Zymeworks and Daiichi Sankyo Expand Immuno-Oncology Collaboration Focused on Bispecific Antibodies

Zymeworks Inc. and Daiichi Sankyo announced that they entered into a new license agreement, building upon their 2016 cross-licensing and collaboration agreement. “With a successful track record and our first bispecific antibody incorporating the Azymetric and EFECT technology having achieved a key research milestone in 2017, we look forward to adding two more bispecific compounds to our pipeline,” said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. “We…

Lilly to Acquire AurKa Pharma

Eli Lilly and Company announced an agreement to acquire AurKa Pharma, Inc., a company established by TVM Capital Life Science to develop oncology compound AK-01, an Aurora kinase A inhibitor that was originally discovered at Lilly. The compound is a potential first-in-class asset that AurKa Pharma is studying in Phase 1 clinical trials in multiple types of solid tumors. Aurora kinases are believed to play a crucial role in cellular division by controlling chromosomal segregation. Defects in segregation can cause genetic…