Top Pharma News | August - September 2017

Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) in MSI-H or dMMR Metastatic Colorectal Cancer That Has Progressed Following Treatment with a Fluoropyrimidine, Oxaliplatin, and Irinotecan

August 01, 2017

Bristol-Myers Squibb Company has announced that the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection for intravenous use for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. Approval for this indication has been granted under accelerated approval based on overall response rate (ORR) and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

U.S. FDA Approves IMBRUVICA® (ibrutinib) as First and Only Approved Treatment for Adult Patients with Chronic Graft-Versus-Host-Disease (cGVHD) After Failure of One or More Lines of Systemic Therapy

August 2, 2017

The U.S. Food and Drug Administration (FDA) has approved IMBRUVICA® (ibrutinib) for the treatment of adult patients with chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy. IMBRUVICA is the first and only FDA-approved medication for adult patients with cGVHD, a potential consequence of an allogeneic stem cell or bone marrow transplant, which can be life-threatening and debilitating. IMBRUVICA is a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor jointly developed and commercialized by Janssen Biotech, Inc., and Pharmacyclics LLC, an AbbVie company.

Bristol-Myers Squibb to Acquire IFM Therapeutics to Strengthen Oncology Pipeline Focus on Innate Immunity

August 3, 2017

Bristol-Myers Squibb Company and IFM Therapeutics (IFM) have announced that the companies have signed a definitive agreement under which Bristol-Myers Squibb will acquire all of the outstanding capital stock of IFM Therapeutics, a venture-backed biotech company focused on developing therapies that modulate novel targets in the innate immune system to treat cancer, autoimmunity and inflammatory disorders.

Dermira Enters into Agreement to License Exclusive, Worldwide Rights to Lebrikizumab

August 08, 2017

Dermira, Inc. has announced that it has entered into a licensing agreement with F. Hoffmann-La Roche Ltd and Genentech, Inc., a member of the Roche Group (together Roche). Pursuant to the agreement, Dermira will obtain exclusive, worldwide rights to develop and commercialize lebrikizumab, a monoclonal antibody targeting interleukin 13 (IL-13), for atopic dermatitis and all other indications, except Roche will retain certain rights, including exclusive rights to develop and promote lebrikizumab for interstitial lung diseases, such as idiopathic pulmonary fibrosis.

Bristol-Myers Squibb Announces Topline Results from CheckMate -214, a Phase 3 Study of Opdivo in Combination with Yervoy in Intermediate and Poor-Risk Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

August 15, 2017

Bristol-Myers Squibb announced topline results today from the CheckMate -214 trial investigating Opdivo (nivolumab) in combination with Yervoy (ipilimumab) versus sunitinib in intermediate and poor-risk patients previously untreated advanced or metastatic renal cell carcinoma. The combination met the co-primary endpoint of objective response rate (ORR) and achieved a 41.6% ORR versus 26.5% for sunitinib. 

Pfizer receives U.S. FDA approval for Besponsa® (inotuzumab ozogamicin)

August 17, 2017

Pfizer Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved BESPONSA® (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). BESPONSA was reviewed and approved under the FDA’s Breakthrough Therapy designation and Priority Review programs.

Lynparza receives additional and broad approval in the US for ovarian cancer

17 August 2017

AstraZeneca and Merck & Co., Inc. have announced that the US Food and Drug Administration (FDA) has granted approval for the PARP inhibitor, Lynparza (olaparib), as follows:

• New use of Lynparza as a maintenance treatment for recurrent, epithelial ovarian, fallopian tube or primary peritoneal adult cancer who are in response to platinum-based chemotherapy, regardless of BRCA status;
• New use of Lynparza tablets (2 tablets twice daily) as opposed to capsules (8 capsules twice daily);
• Lynparza tablets also now indicated (conversion from the current accelerated approval) for the use in patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer, who have been treated with three or more prior lines of chemotherapy.

Adamas Announces FDA Approval of GOCOVRI™ as First and Only Medication for the Treatment of Dyskinesia in Parkinson's Disease Patients

August 24, 2017

Adamas Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved GOCOVRI (amantadine) extended release capsules (previously ADS-5102) for treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. GOCOVRI, previously granted orphan drug status by the FDA, is the first and only medicine approved by the FDA for this indication.

Genmab Announces Positive Topline Results in Phase III ALCYONE Study of Daratumumab in Front Line Multiple Myeloma

August 24, 2017

Genmab A/S has announced topline results from the Phase III ALCYONE study (MMY3007) of daratumumab in combination with bortezomib, melphalan and prednisone (VMP) versus VMP alone as front line treatment for newly diagnosed patients who are not considered candidates for autologous stem cell transplantation (ASCT). The study met the primary endpoint of improving progression free survival (PFS) at a pre-planned interim analysis (Hazard Ratio (HR) = 0.50 (95% CI 0.38-0.65), p < 0.0001). Treatment with daratumumab reduced the risk of disease progression or death by 50%, as compared to those who did not receive daratumumab. The median PFS for patients treated with daratumumab in combination with VMP has not been reached, compared to an estimated median PFS of 18.1 months for patients who received VMP alone. Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab

Extended treatment with Brilinta reduces risk of cardiovascular death by 29% in patients with history of heart attack

24 August 2017

AstraZeneca has announced results from a new sub-analysis of data from the Phase III PEGASUS-TIMI 54 trial demonstrating a 29% risk reduction in CV death (p=0.0041) from treatment with Brilinta (ticagrelor) 60mg twice daily, versus placebo, in patients taking low-dose aspirin but still at high risk of an atherothrombotic event, a major cause of acute coronary syndrome and CV death.

European Commission Grants Approval for Mavenclad for the treatment of highly active relapsing multiple sclerosis (RMS)

August 25, 2017

Merck KGaA has announced that the European Commission (EC) has granted marketing authorization for MAVENCLAD® 10mg (Cladribine Tablets) for the treatment of highly active relapsing multiple sclerosis (RMS) in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland. MAVENCLAD® is the first oral short-course treatment to provide efficacy across key measures of disease activity in patients with highly active RMS, including disability progression, annualized relapse rate and magnetic resonance imaging (MRI) activity.

Novartis Phase III CANTOS study demonstrates that targeting inflammation with ACZ885 reduces cardiovascular risk

August 27, 2017

Novartis has revealed primary data from CANTOS, a Phase III study evaluating ACZ885 (canakinumab) in people with a prior heart attack and inflammatory atherosclerosis. Trial participants received either placebo or one of three doses of ACZ885 in combination with current standard of care therapies, with 91% of them taking lipid-lowering statins. The study showed that ACZ885 led to a statistically significant 15% reduction in the risk of major adverse cardiovascular events (MACE), a composite of non-fatal heart attack, non-fatal stroke and cardiovascular death, compared to placebo (p-value 0.021). Additionally, a review of blinded, pre-planned oncology safety analyses revealed a 77% reduction in lung cancer mortality and 67% reduction in lung cancer cases in patients treated with 300mg of ACZ885

Gilead Sciences to Acquire Kite Pharma for $11.9 Billion

August 28, 2017

Gilead Sciences, Inc. and Kite Pharma, Inc. have announced that the companies have entered into a definitive agreement pursuant to which Gilead will acquire Kite for $180.00 per share in cash. The transaction, which values Kite at approximately $11.9 billion, was unanimously approved by both the Gilead and Kite Boards of Directors and is anticipated to close in the fourth quarter of 2017.

You may also be interested in the following analyses and perspectives:

The World’s Healthiest Countries 2017

This year Bloomberg published the ranking of the 50 healthiest countries in the world and results are quite surprising. Italy got the highest score and Iceland, Switzerland, Singapore and Australia complete the list of the top 5.

Top 20 Drugs in the World 2017

The global prescription drug market is expected to grow by 6% from 2016 to 2022 to reach nearly USD 1.05 trillion by 2022. The top 20 drugs are manufactured by 14 companies and account for a total 10% of global prescription drug market in 2016. The total revenue generated by top 20 products was estimated to be USD 0.128 trillion.

Top 10 Pharmaceutical Therapy Areas in 2017

Many new medications and treatments have emerged this year for improving the management and prognoses of patients suffering from serious diseases. Driven growing therapy areas such as oncology, anti-rheumatics, and anti-virals, the prescription drug sales are increasing significantly. 

Top 10 Oncology Pharmaceutical Companies 2017

The market for oncology medication is booming, aiding the overall pharmaceutical industry growth. The oncology drug market is estimated to be almost USD 94 billion. Most of the top pharmaceutical players are either currently manufacturing oncology drugs or have oncology medications in their R&D pipelines.

Top 10 Pharmaceutical Companies 2017: Anti-Rheumatics

Rheumatic diseases are chronic diseases involving the inflammation and severe pain in joints, tendons, ligaments, bones, and muscles. Examples of rheumatic diseases include Osteoarthritis, Rheumatoid arthritis, Fibromyalgia, Gout, Psoriatic arthritis, Scleroderma, etc. Complications induced by rheumatic diseases can lead to lower articular function and higher mortality. In addition, these can affect the ability of the patients to work properly, and also affect their social relationships. Hence, medical researchers have devoted their time and efforts to develop effective drugs for the treatment of these diseases.

Medical Science Liaison (MSL): Why Pharmacists make a good (or even better) MSL candidate

The Medical Science Liaison (MSL) role is often associated with PhDs, postdocs and in some counties with an MD degree. But we know from our 2017 global MSL salary survey that quite a few MSLs globally have a pharmacist background. For instance, in the US and Portugal, 27% and 22% of the MSLs had a PharmD degree, respectively. And in Australia we know there is quite a high percentage of BPharm and/or MPharm trained MSLs. Becoming an MSL as a pharmacist is not always mentioned as a career path. So, what can make a pharmacist a good MSL candidate?

Luca Dezzani is a Novartis employee. All the views, analysis, and perspectives are fully independent and belongs to the author only. They do not represent the views or opinions of Novartis or any other company or organization. IgeaHub is a pharmaceutical blog created and curated by Luca Dezzani.  IgeaHub does not receive any funding or support from Novartis or any other pharmaceutical company.