November 2016

2 November 2016

Invites for Postdoctoral Post in Indian Institute of Technology | Salary upto 40 - 55,000 per month

We are seeking for talented, motivated and passionate individuals to join in our efforts for leading-edge research on “* Combinational therapy against breast and colorectal cancer *”. The candidate will get highly interdisciplinary work environment to perform cutting age research. As this INNO INDIGO project is an internationally collaborative project (Belgium, Norway and India) postdoctoral fellow will closely work with collaborators from the European Countries and will have opportunity to visit to Belgium/Norway to accomplish the project work. Candidate need to spend time in the European partner laboratory up to 6 months.

Post : Postdoctoral Post

2 November 2016

Seminar on ‘Medical Electronics: International Collaborations & Financing for Manufacturing in India'

As you may be aware, PHD Chamber of Commerce & Industry, a leading Industry Chamber of India, ever since its inception in 1905, has been an active participant in the India Growth Story through its Advocacy Role for the Policy Makers and Regulators of the Country. Regular interactions, Seminars, Conference and Conclaves allow healthy and constructive discussions between the Government, Industry and International Agencies bringing out the Vitals for Growth. As a true representative of the Industry with a large membership base of 48000 direct and indirect members, PHD Chamber has forged ahead leveraging its legacy with the Industry knowledge across sectors (58 Industry verticals being covered through Expert Committees), a deep understanding of the Economy at large and the populace at the micro level. At a Global level we have been working with the Embassies and High Commissions in India to bring in the International Best Practices and Business Opportunities. Industrial Development, Health, Education & Skill development, Housing, Infrastructure, Agriculture & Agri-business and Digital India are the seven key thrust areas of the Chamber. Medical devices play a role not only in screening, diagnosing and treating patients, but also in restoring patients to normal lives and in regularly monitoring health indicators to prevent diseases

Read more about USFDA, EMA accept Biogen's Nusinersen NDA

Biogen announced that its New Drug Application (NDA) for nusinersen, an investigational treatment for spinal muscular atrophy (SMA), has been accepted by the US Food and Drug Administration (FDA) for Priority Review, and that the company’s Marketing Authorization Application (MAA) has been validated by the European Medicines Agency (EMA). Nusinersen had previously been granted Accelerated Assessment status by the EMA’s Committee for Medicinal Products for Human Use (CHMP). The regulatory review process for these applications has now been initiated in the US and EU. Both the Priority Review and Accelerated Assessment designations can reduce the standard review time. If approved, nusinersen would be the first therapy for SMA, a leading genetic cause of infant mortality.

ARIAD Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ARIAD’s investigational oral anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, in patients with metastatic ALK-positive (ALK+) non-small cell lung cancer (NSCLC) who have progressed on crizotinib. The FDA granted ARIAD’s request for Priority Review and has set an action date of April 29, 2017 under the Prescription Drug User Fee Act (PDUFA).

“The FDA acceptance of our application is an important milestone in our ongoing efforts to discover, develop and deliver highly innovative treatments for patients with rare cancers,” said Paris Panayiotopoulos, president and chief executive officer of ARIAD. “We are pleased that our significant R&D investments in brigatinib and our work with the FDA are bringing us closer to potentially offering a treatment option for patients with ALK+ NSCLC who are refractory to crizotinib. We look forward to continuing to work closely with the FDA during the brigatinib NDA review and remain committed to developing critical therapies for unserved and underserved small patient populations suffering from rare cancers.”

ARIAD’s NDA submission includes clinical data from its Phase 1/2 and pivotal Phase 2 ALTA trials of brigatinib. The FDA’s Priority Review status accelerates the review time from 10 months to a goal of six months from the filing of the application. Brigatinib received Breakthrough Therapy designation from the FDA for the treatment of patients with ALK+ NSCLC whose tumors are resistant to crizotinib, and was granted orphan drug designation by the FDA for the treatment of ALK-positive, ROS1-positive, and EGFR-positive NSCLC. ARIAD plans to submit a Marketing Authorization Application (MAA) for brigatinib to the European Medicines Agency (EMA) in early 2017.

ARIAD is a small, research-driven biotechnology company. ARIAD has invested more than USD 1.3 billionin R&D since the Company was founded. In 2015, ARIAD generated USD 119 million in total revenue and invested USD 171 million, or 143 percent of revenue, in R&D.

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Read more about FDA approves St. Jude Amplatzer PFO Occluder device

The U.S. Food and Drug Administration approved the Amplatzer PFO Occluder device. The PFO Occluder reduces the risk of a stroke in patients who previously had a stroke believed to be caused by a blood clot that passed through a small hole in the heart, called a patent foramen ovale (PFO), and then traveled to the brain. The Amplatzer PFO Occluder device is manufactured by St. Jude Medical Inc. based in Plymouth, Minnesota.

Read more about Catalyst Pharmaceuticals Receives SPA from FDA for Second Phase 3 Clinical Trial for Evaluating Firdapse

Catalyst Pharmaceuticals, Inc. announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the protocol design, clinical endpoints, and statistical analysis approach to be taken in Catalyst's upcoming Phase 3 study evaluating Firdapse® (amifampridine phosphate) for the symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS).

2 November 2016

Vertex's long-term data from Orkambi + Kalydeco shows potential to modify progression of cystic fibrosis

Vertex Pharmaceuticals Incorporated announced the presentation of long-term data demonstrating that Orkambi (lumacaftor/ivacaftor) and Kalydeco (ivacaftor) show the potential to modify the progression of cystic fibrosis (CF).

Read more about Sanofi and Regeneron Receive CRL from FDA for Sarilumab

Sanofi and Regeneron Pharma Inc. announced the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the Biologics License Applications (BLA) for sarilumab, an investigational interleukin-6 receptor (IL-6R) antibody for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

Read more about GSK announce new data for shingles candidate vaccine, Shingrix at IDWeek scientific conference

GSK announced new data for its shingles candidate vaccine Shingrix, at the Infectious Disease Week (IDWeek) scientific conference in New Orleans, Louisiana, USA. The data examined co-administration of GSK’s candidate vaccine with the flu vaccine; a flexible dosing schedule; and the vaccine’s impact on quality of life.

Read more about Allergan get US FDA approval for Restasis Multidose for chronic dry eye

Allergan plc announced that it has received approval from the US Food and Drug Administration (FDA) for Restasis Multidose (Cyclosporine Ophthalmic Emulsion) 0.05%, a preservative-free, multi-dose bottle offering the same preservative-free formulation of Restasis since the launch in 2003. Restasis is the one and only prescription treatment FDA approved to help patients with a type of chronic dry eye make more of their own tears.