Top 20 World Pharma News of 2018

1. New research paper shows that AstraZeneca has achieved greater than four-fold improvement in R&D productivity

In a research paper published today by Nature Reviews Drug Discovery(1), AstraZeneca’s IMED Biotech Unit documents a more than four-fold improvement in R&D productivity following significant revision of its approach and adoption of a ‘5R framework’ – right target, right patient, right tissue, right safety, right commercial potential.

2. Roche to acquire Flatiron Health to accelerate industry-wide development and delivery of breakthrough medicines for patients with cancer

Roche (SIX: RO, ROG; OTCQX: RHHBY) and Flatiron Health, Inc. announced that the two partners have signed a definitive agreement under which Roche will acquire all shares of Flatiron Health, following on from an existing equity stake of 12.6%. The transaction is expected to close in the first half of 2018.

3. FDA highlights record-breaking number of generic drug approvals in October

Today, the U.S. Food and Drug Administration is providing a summary of the generic drug approval actions for the month of October 2018 as part of its efforts to improve patient access to high-quality, lower cost, safe and effective medicines. In October, the FDA approved 110 generic drugs and tentatively approved 18 generic drugs, for a total of 128 approval actions.

4. GSK reaches agreement with Novartis to acquire full ownership of Consumer Healthcare Business

GlaxoSmithKline plc (LSE/NYSE: GSK) today announces that it has reached an agreement with Novartis for the buyout of Novartis’ 36.5% stake in their Consumer Healthcare Joint Venture for $13 billion (£9.2 billion). The Consumer Healthcare Joint Venture was formed as part of the three-part transaction between GSK and Novartis which was approved by shareholders in 2014.

5. FDA approves first cancer drug through new oncology review pilot that enables greater development efficiency

The U.S. Food and Drug Administration today approved Kisqali (ribociclib) in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy.

6. Delivering insulin in a pill

Given the choice of taking a pill or injecting oneself with a needle, most of us would opt to regulate a chronic health condition by swallowing a pill. But for millions of people living with type 1 diabetes, a painful needle prick once or twice daily is the only option for delivering the insulin that their bodies cannot produce on their own.

7. Bristol-Myers Squibb’s Opdivo® (nivolumab) now the first and only FDA-approved PD-1 inhibitor to offer every four-week dosing

Bristol-Myers Squibb Company (NYSE:BMY) announced the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) updating the Opdivo ® (nivolumab) dosing schedule to include 480 mg infused every four weeks (Q4W) for a majority of approved indications.

8. FDA approves first treatment for breast cancer with a certain inherited genetic mutation

The U.S. Food and Drug Administration today expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast cancer that have spread (metastasized) and whose tumors have a specific inherited (germline) genetic mutation, making it the first drug in its class (PARP inhibitor) approved to treat breast cancer, and it is the first time any drug has been approved to treat certain patients with metastatic breast cancer who have a “BRCA” gene mutation.

9. Researchers artificially generate immune cells integral to creating cancer vaccines

For the first time, Mount Sinai researchers have identified a way to make large numbers of immune cells that can help prevent cancer reoccurrence, according to a study published in August in Cell Reports. The researchers discovered a way to grow the immune cells, called dendritic cells, at large scale in the lab to study them for their potential use in highly refined cancer vaccines to prevent patients’ cancer from coming back.

10. Pfizer receives Breakthrough Therapy designation from FDA for PF-04965842, an oral JAK1 Inhibitor, for the treatment of patients with moderate-to-severe atopic dermatitis

Pfizer Inc. (NYSE:PFE) today announced its once-daily oral Janus kinase 1 (JAK1) inhibitor PF-04965842 received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with moderate-to-severe atopic dermatitis (AD). The Phase 3 program for PF-04965842 initiated in December and is the first trial in the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program.

11. For first time in 40 years, cure for acute leukemia within reach

Acute myeloid leukemia is one of the most aggressive cancers. While other cancers have benefitted from new treatments, there has been no encouraging news for most leukemia patients for the past 40 years. Until now. As published today in the scientific journal Cell, Professor Yinon Ben-Neriah and his research team at the Hebrew University of Jerusalem (HU)’s Faculty of Medicine have developed a new biological drug with a cure rate of 50% for lab mice with acute leukemia.

12. Consuming milk at breakfast lowers blood glucose throughout the day

A change in breakfast routine may provide benefits for the management of type 2 diabetes, according to a new study published in the Journal of Dairy Science. H. Douglas Goff, PhD, and the team of scientists from the Human Nutraceutical Research Unit at the University of Guelph, in collaboration with the University of Toronto, examined the effects of consuming high-protein milk at breakfast on blood glucose levels and satiety after breakfast and after a second meal.

13. FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease

The U.S. Food and Drug Administration today approved Onpattro (patisiran) infusion for the treatment of peripheral nerve disease (polyneuropathy) caused by hereditary transthyretin-mediated amyloidosis (hATTR) in adult patients. This is the first FDA-approved treatment for patients with polyneuropathy caused by hATTR, a rare, debilitating and often fatal genetic disease characterized by the buildup of abnormal amyloid protein in peripheral nerves, the heart and other organs.

14. New cancer treatment uses enzymes to boost immune system and fight back

Researchers at The University of Texas at Austin have developed a new approach to treating cancer using enzyme therapy. The enzyme, PEG-KYNase, does not directly kill cancer cells but instead empowers the immune system to eradicate unwanted cells on its own. PEG-KYNase is designed to degrade kynurenine, a metabolite produced by numerous tumors that suppresses the immune system.

15. Bayer accelerates six new startups

Changing the experience of health: that’s the focus of the six startups which the Bayer G4A team has included in the Accelerator program this year. The young companies from Canada, Germany, Israel, Spain, the United Kingdom and the United States came out ahead of more than 1,800 competitors from 100 countries.

16. Novartis advances head-to-head superiority trials of Cosentyx® versus Humira® and proposed biosimilar adalimumab

Novartis announced today the initiation of SURPASS, a head-to-head clinical trial of Cosentyx® (secukinumab) versus proposed biosimilar adalimumab in ankylosing spondylitis (AS). SURPASS is the first head-to-head clinical trial in AS investigating superiority of Cosentyx in slowing spinal bone damage versus proposed biosimilar adalimumab. SURPASS is currently recruiting patients, with the ‘first patient first visit’ already achieved in November 2017.

17. New approach to fight tuberculosis, a leading cause of death worldwide

Tuberculosis is one of the top 10 causes of death worldwide. Nearly 2 million people die every year from this infectious disease, and an estimated 2 billion people are chronically infected. The only vaccine, developed almost 100 years ago, offers limited protection and patients are becoming increasingly resistant to available drugs.

18. Most popular vitamin and mineral supplements provide no health benefit, study finds

The most commonly consumed vitamin and mineral supplements provide no consistent health benefit or harm, suggests a new study led by researchers at St. Michael’s Hospital and the University of Toronto. Published today in the Journal of the American College of Cardiology, the systematic review of existing data and single randomized control trials published in English from January 2012 to October 2017 found that multivitamins, vitamin D, calcium and vitamin C – the most common supplements – showed no advantage or added risk in the prevention of cardiovascular disease, heart attack, stroke or premature death.

19. FDA permits marketing of artificial intelligence-based device to detect certain diabetes-related eye problems

The U.S. Food and Drug Administration today permitted marketing of the first medical device to use artificial intelligence to detect greater than a mild level of the eye disease diabetic retinopathy in adults who have diabetes. Diabetic retinopathy occurs when high levels of blood sugar lead to damage in the blood vessels of the retina, the light-sensitive tissue in the back of the eye.

20. The Nobel Prize in Physiology or Medicine 2018 was awarded jointly to James P. Allison and Tasuku Honjo “for their discovery of cancer therapy by inhibition of negative immune regulation.”

Cancer kills millions of people every year and is one of humanity’s greatest health challenges. By stimulating the inherent ability of our immune system to attack tumor cells this year’s Nobel Laureates have established an entirely new principle for cancer therapy.