FDA ban

The first quarter of 2016 hosted plenty of activity from the pharma and cold chain industries. This was seen in the form of patent challenges, landmark agreements, extreme market reactions as well as a nationwide medicine ban for hundreds of products. Read on for this quarter’s highlights from Cold Chain IQ & Pharma IQ.

Biotech firm sets its eyes on launching the first biologistic drone

Flash Biologistic has joined the Drones For Life project with the view to make the idea of isothermal packaging drones in health service logistics an everyday reality.

Test flights are due to be happening in Bordeaux this summer.

Agro Merchants acquires Spanish Cold Storage Leader

Cold Chain service provider, Agro Merchants Group acquires APC which provides a range of storage facilities with temperature control capacities.

UPS unveils Cryo Shipping Service in Europe

UPS launched its cryogenic containers this quarter known as Temperature True, maintaining temperatures at -150 degrees for 10 days in transit through the use of liquid nitrogen in dry vapor form. The technology has real time monitoring and intervention.

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Regulator Update:

India’s Health Ministry Bans Over 330 Combination Drugs

The notification which was published in early March stated the near to immediate prohibition of manufacture or sale of over 300 fixed drug combination medicines, a lot of which are sold over the counter. Many of these decisions were made on the basis that there were safer alternatives available on the market and therefore the drugs were found to have no therapeutic justification. Combinations include: Aceclofenac + Paracetamol + Rabeprazole, Paracetamol + Cetirizine + Caffeine

FDA poses ban on Most Powdered Gloves

In this quarter the body lodged a proposal to ban gloves on the grounds that they propose a risk to health of care providers, patients.

The body stated in release: “ these devices are associated with an extensive list of potentially serious adverse events, including severe airway inflammation, wound inflammation, and post-surgical adhesions, which are bands of fibrous scar tissue that form between internal organs and tissues. These side effects have been attributed to the use of glove powder with all types of gloves.”

EU launches PRIME scheme

At the end of this quarter the EU launched a priority medicines scheme (PRIME). This initiative will fast track medicines that target uncatered medical needs. The Commission has reduced the timeframe for adopting decisions to authorize said medicines and support developers in the discovery of data to promote benefits.

First coagulation factor-albumin fusion protein to treat patients with hemophilia B gets FDA approval

“The approval of Idelvion provides another important therapeutic option for children and adults with Hemophilia B to help prevent or control bleeding and reduce the frequency of bleeding episodes,” said Peter Marks, M.D., Ph.D., Director of the FDA’s Center for Biologics Evaluation and Research.

Market update:

Valeant Pharmaceuticals experiences extreme market reaction

Valeant Pharmaceuticals experienced an extreme market reaction to its fourth-quarter preliminary unaudited financial results, which caused its stock price to suffer a sheer fall.

The transition from Philidor was pinpointed as an influencer in hurting the Q4 results.

Although, outside pressure from managed care, pricing conditions, a ‘slower-than expected start to 2016’ are said to have had an impact on the business, in an announcement online, CEO Mike Pearson comforted Valeant Employees that the business is still in a state of growth, is strong and headed in the right direction.

Parkinson’s Disease stands as one of the globe’s most dominant neurodegenerative diseases

According to a recent research report, Parkinson’s Disease is the second most common neurodegenerative disease worldwide.

Tissue engineering market forecasted to hit US$11.5 bn by 2022

Due to the interest shifting from stem cell therapies to immunocellular therapies, the tissue engineering market is charted to reach just over US$11.5 billion by the year of 2022.

Over 40,000 patients gain Hepatitis C treatment with next generation drugs in Spain

Since January 2015, over 40,300 patients have been treated by next generation Hepatitis C treatments in Spain. Spain is said to be recognized as one of the first EU countries to incorporate next-generation drugs.

Deals and Agreements:

Merck purchase Harvard Team’s Cancer Drug for US$20 million

The pharma firm has paid US$20 million for an oncology drug produced by a team of scientists at Harvard. This is said to have been the highest upfront cash payment Harvard has ever received from a pharma licensing deal.

Bristol-Myers Squibb to Acquire Padlock Therapeutics, Inc.

Bristol Myers Squibb signed an agreement to acquire the outstanding stock of Padlock – biotechnology company focused on the treatment of destructive autoimmune diseases. The deal is set to further strengthen the firm’s immunoscience pipeline.

Sun Pharma and Astrazeneca enter India partnership focused on Type 2 diabetes

The two firms announced their partnership for the collaborative distribution of dapagliflozin, an innovative Type 2 diabetes medicine, in India.

One of India’s biggest pharma manufacturing names enters agreement for ‘underserved niche’

Moberg Pharma and Cadila Pharmaceuticals Limited – one of India’s largest healthcare manufacturing groups – entered a Development and License Agreement for BUPI – a novel lozenge formulation of bupivacaine for pain management in oral mucositis patients – which has been labelled as an underserved niche.

Science Exchange lands $25m funding line.

The Science Exchange raised $25 million in new funding. The capital injection was led by Maverick Capital Ventures and also included participation from Union Square Ventures, Index Ventures, OATV, Collaborative Fund, YC Continuity Fund, Jose Suarez (CEO of TEDMED), Sam Altman, Steve Case, Paul Buchheit, and others.

Reports state that the marketplace for scientific research services is used by 8 out of the 10 top pharmaceutical companies.

Allergan files patent challenge

Allergan filed a patent challenge with the FDA in regards to the generic version of Celgene’s Abraxane – a treatment for metastatic breast cancer after failure of combination chemotherapy. Reports indicated that “Allergan believes it is a "first applicant" to file an ANDA for the generic version of Abraxane® and, should it's ANDA be approved, may be entitled to 180 days of generic market exclusivity.”

This Quarter’s best content

Click on the headlines below to view the content:

CROS Top 10 Clinical Research Organisations in the Pharma & Biotech Industry for 2016 Pharma & Biotech’s Merger Fever: The Highlights Biological Sample Management & Gaining Access to Diverse Samples: The Web of Collaboration Smarter Next Generation Innovation & Cost Effectiveness In Compound Management Do's And Don’ts: GMP Risk Assessments For Cross Contamination Between Products. How Life Sciences Evolve Logistics Functions to Unleash Their Competitive Advantage Johnson & Johnson’s Award Winning Cool Chain Project

FDA ban

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