Top Pharma News | October – November 2017



Amgen And CytomX Therapeutics Announce Strategic Collaboration in Immuno-Oncology

October 3, 2017

Amgen and CytomX Therapeutics, Inc. have announced that the companies have entered into a strategic collaboration in immuno-oncology. The companies will co-develop a CytomX Probody™ T-cell engaging bispecific against the Epidermal Growth Factor Receptor (EGFR), a highly validated oncology target expressed on multiple human cancer types. Probody T-cell engaging bispecifics are antibody constructs capable of directing cytotoxic T-cells in tumor microenvironments. In preclinical studies, CytomX’s Probody versions of EGFRxCD3 bispecific therapeutics induced tumor regressions and increased the therapeutic window for this high potential cancer target.


Lilly Receives U.S. FDA Approval of Verzenio™ (abemaciclib)

October 4, 2017

Eli Lilly and Company has announced that the U.S. Food and Drug Administration (FDA) has approved Verzenio™ (abemaciclib) in combination with fulvestrant for the treatment of women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer with disease progression following endocrine therapy, and as monotherapy for the treatment of adult patients with HR+, HER2- advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting. It is the first and only CDK4 & 6 inhibitor FDA approved in combination with fulvestrant and as monotherapy. The approval of Verzenio was received on September 28, 2017.




FDA approves Roche cobas Zika as first commercially-available donor screening test for Zika virus

October 6, 2017

Roche has announced that it has received approval from the U.S. Food and Drug Administration (FDA) for the cobas® Zika test for use on the cobas 6800/8800 Systems. The cobas Zika test is the first commercially available test for the detection of the Zika virus RNA in samples of human plasma intended for use in screening blood donations. This approval marks an important milestone in the effort to protect the blood supply from Zika virus in the U.S.

Flexion Therapeutics Announces FDA Approval of Zilretta™ (triamcinolone acetonide extended-release injectable suspension) for Osteoarthritis (OA) Knee Pain

October 6, 2017

Flexion Therapeutics, Inc. has announced that the U.S. Food and Drug Administration (FDA) approved Zilretta™ (triamcinolone acetonide extended-release injectable suspension), the first and only extended-release, intra-articular injection for osteoarthritis knee pain. Zilretta is a non-opioid medicine that employs Flexion’s proprietary microsphere technology to provide proven pain relief over 12 weeks.


Tagrisso granted breakthrough therapy designation by US FDA for the 1st-line treatment of patients with EGFR mutation-positive non-small cell lung cancer

October 9, 2017

AstraZeneca has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Tagrisso (osimertinib) for the 1st-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC).


Lilly Reports Topline Results from Phase 3 JUNIPER Trial Evaluating Verzenio™ (abemaciclib) in KRAS-Mutated, Advanced Non-Small Cell Lung Cancer

October 10, 2017

Eli Lilly and Company has announced that its Phase 3 JUNIPER study evaluating Verzenio™ (abemaciclib), a cyclin-dependent kinase (CDK)4 and CDK6 inhibitor, as monotherapy in KRAS-mutated, advanced non-small lung cancer (NSCLC) did not meet its primary endpoint of overall survival (OS). However, an analysis of the secondary study endpoints of both progression-free survival (PFS) and overall response rate (ORR) showed evidence of monotherapy activity in the abemaciclib arm. In addition, the control arm showed a higher overall survival rate than expected based on historical data in this setting.




CHMP Issues a Positive Opinion on Janssen’s ZYTIGA® to Include Earlier Stage Prostate Cancer Patients

October 13, 2017

Janssen-Cilag International NV has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended broadening the existing marketing authorisation for ZYTIGA® (abiraterone acetate) plus prednisone / prednisolone to include an earlier stage of prostate cancer than its current indications. If approved by the European Commission, abiraterone acetate plus prednisone / prednisolone in combination with androgen deprivation therapy (ADT) can be used for the treatment of adult men with newly diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHSPC).

CHMP recommends EU approval of Roche’s Alecensa (alectinib) as a first-line treatment for people with ALK-positive NSCLC

October 13, 2017

Roche has announced that the European Union’s (EU) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Alecensa® (alectinib) as a monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive, advanced non-small cell lung cancer (NSCLC). It has also simultaneously recommended the conversion of the current conditional marketing authorisation for Alecensa in crizotinib failure (second-line) to a full marketing authorisation.








Merck’s KEYTRUDA® (pembrolizumab) More Than Doubled Median Overall Survival Compared to Chemotherapy After Two Years of Follow Up in First-Line Treatment of Patients with Metastatic Non-Small Cell Lung Cancer with High Levels of PD-L1

October 18, 2017

Merck has announced the presentation of updated overall survival (OS) findings, a secondary endpoint, from the phase 3 KEYNOTE-024 trial evaluating KEYTRUDA®(pembrolizumab), the company’s anti-PD-1 therapy, as a first-line monotherapy in patients with non-small cell lung cancer (NSCLC) whose tumors express high levels of PD-L1 (tumor proportion score [TPS] of 50 percent or more). The study included patients with squamous and nonsquamous NSCLC with no EGFR or ALK genomic tumor aberrations. Findings – which are based on more than two years of follow-up – were presented in an oral presentation at the 18th World Conference on Lung Cancer (WCLC). With an additional six months of available data, results continue to show a reduction in the risk of death by 37 percent for KEYTRUDA compared to chemotherapy based on more than two years of median follow-up (HR, 0.63 [95% CI, 0.47–0.86]; nominal p=0.002).

AstraZeneca and Chi-Med’s savolitinib shows encouraging clinical activity in 2nd-line EGFR mutation-positive lung cancer with MET-amplification

17 October 2017

AstraZeneca and its partner Chi-Med have presented preliminary safety and clinical activity of savolitinib when given in combination with either Tagrisso (osimertinib) or Iressa (gefitinib) in two Phase Ib trials conducted in patients with epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) with MET-amplification who had progressed following 1st-line treatment with an EGFR inhibitor. In both trials, the addition of savolitinib (600mg, once daily), an investigational selective inhibitor of c-MET (mesenchymal epithelial transition factor) receptor tyrosine kinase, to osimertinib (80mg, once daily) or gefitinib (250mg, once daily) demonstrated preliminary anti-tumour activity.

Semaglutide receives positive 16-0 vote in favour of approval from FDA Advisory Committee

October 18, 2017

Novo Nordisk today announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration (FDA) voted 16-0 in favour of the approval of once-weekly semaglutide to improve glycaemic control in adults with type 2 diabetes. The recommendation for approval was based on a global development programme involving more than 8,000 adults with type 2 diabetes in the eight SUSTAIN phase 3a clinical trials, including a cardiovascular outcomes trial.


Kite’s Yescarta™ (Axicabtagene Ciloleucel) Becomes First CAR T Therapy Approved by the FDA for the Treatment of Adult Patients with Relapsed or Refractory Large B-Cell Lymphoma After Two or More Lines of Systemic Therapy

October 18, 2017

Kite, a Gilead Company, has announced that the U.S. Food and Drug Administration (FDA) has granted regular approval to Yescarta™ (axicabtagene ciloleucel), the first chimeric antigen receptor T cell (CAR T) therapy for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma (transformed follicular lymphoma, or TFL). Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma.



Janssen Receives Two U.S. FDA Approvals for SIMPONI ARIA ® (golimumab) for the Treatment of Adults with Active Psoriatic Arthritis or Active Ankylosing Spondylitisrthritis or Active Ankylosing Spondylitis

October 20, 2017

Janssen Biotech, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved SIMPONI ARIA® (golimumab), the only fully-human anti-tumor necrosis factor (TNF)-alpha therapy administered via a 30-minute infusion, for the treatment of adults with active psoriatic arthritis (PsA) or active ankylosing spondylitis (AS). The PsA and AS approvals are supported by comprehensive clinical development programs that demonstrated the significant efficacy of SIMPONI ARIA® over placebo, while offering a consistent safety profile across all indications. In the study for the treatment of active PsA, patients experienced improvement in joint symptoms and inhibition of structural damage. In the study for treatment of active AS, results showed improvement in measures of disease activity.

Incyte and MacroGenics Announce Global Collaboration and Licensing Agreement for Anti-PD-1 Monoclonal Antibody MGA012

October 25, 2017

Incyte Corporation and MacroGenics, Inc. have announced that the companies have entered into an exclusive global collaboration and license agreement for MacroGenics’ MGA012, an investigational monoclonal antibody that inhibits programmed cell death protein 1 (PD-1). Incyte has obtained exclusive worldwide rights for the development and commercialization of MGA012 in all indications, while MacroGenics retains the right to develop its pipeline assets in combination with MGA012.


Risankizumab Meets All Co-Primary and Ranked Secondary Endpoints, Achieving Significantly Greater Efficacy Versus Standard Biologic Therapies in Three Pivotal Phase 3 Psoriasis Studies

October 26, 2017

AbbVie, a global research and development-based biopharmaceutical company, has announced positive top-line results from three pivotal Phase 3 clinical trials evaluating risankizumab, an investigational interleukin-23 (IL-23) inhibitor, compared to ustekinumab and adalimumab for the treatment of patients with moderate to severe chronic plaque psoriasis. Results showed that after 16 weeks of treatment, risankizumab (150 mg) met the co-primary endpoints of at least a 90 percent improvement in the Psoriasis Area and Severity Index (PASI 90) and a static Physician Global Assessment (sPGA) score of clear or almost clear (sPGA 0/1) across all three studies versus placebo or adalimumab (based on trial design). Risankizumab is not approved by regulatory authorities and its safety and efficacy have not been established.

Novartis PARADIGMS data show children and adolescents with MS had an 82% lower relapse rate with Gilenya® vs. interferon beta-1a

October 28, 2017

Novartis has announced full results from the positive Phase III PARADIGMS study, investigating the safety and efficacy of Gilenya® (fingolimod) vs. interferon beta-1a, in children and adolescents (ages 10 to 17) with multiple sclerosis (MS). Treatment with oral Gilenya resulted in an 82% reduction in the rate of relapses (annualized relapse rate) over a period of up to two years, compared to interferon beta-1a intramuscular injections (p <0.001). PARADIGMS is the first ever controlled, randomized trial specifically designed for pediatric MS.

Efficacy and Safety Results from Second Phase III Trial (RADIANCE™ Part B) of Oral Ozanimod Versus an Active Comparator in Relapsing Multiple Sclerosis Presented at MSParis2017

October 28, 2017

Celgene Corporation has announced detailed results from the phase III RADIANCE™ Part B trial evaluating the efficacy and safety of ozanimod, a novel, oral, selective sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator, versus a first-line treatment, Avonex® (interferon beta-1a) (IFN), in patients with relapsing multiple sclerosis (RMS). The study evaluated two doses (1 mg and 0.5 mg) of oral ozanimod compared with IFN in 1,320 patients with RMS in 21 countries treated for two years. A significant reduction in annualized relapse rate (ARR) was demonstrated for ozanimod 1 mg (ARR=0.17, p < 0.0001) and for ozanimod 0.5 mg (ARR=0.22, p=0.0167) compared with IFN (ARR=0.28) over two years of treatment.

Novartis announces the planned acquisition of Advanced Accelerator Applications to strengthen oncology portfolio

October 30, 2017

Novartis has announced that it has entered a memorandum of understanding with Advanced Accelerator Applications (AAA) under which Novartis intends to commence a tender offer for 100% of the share capital of AAA subject to certain conditions. Advanced Accelerator Applications is a radiopharmaceutical company that develops, produces and commercializes Molecular Nuclear Medicines including Lutathera® (177Lu-DOTATATE), a first-in-class RLT product for neuroendocrine tumors (NETs). Radiopharmaceuticals, such as Lutathera, are unique medicinal formulations containing radioisotopes which are used clinically for both diagnosis and therapy. The transaction would strengthen Novartis’ oncology presence with both near-term product launches as well as a new technology platform with potential applications across a number of oncology early development programs.

European Medicines Agency Validates Bristol-Myers Squibb’s Type II Variation Application for Opdivo (nivolumab) for Treatment of Patients with Resected High-Risk Advanced Melanoma

October 30, 2017

Bristol-Myers Squibb Company has announced that the European Medicines Agency (EMA) validated its type II variation application, which seeks to expand the current indications for Opdivo (nivolumab) to include the treatment of patients with melanoma who are at high risk of disease recurrence following complete surgical resection. Validation of the application confirms the submission is complete and begins the EMA’s centralized review process.

Novartis submits application to FDA for KymriahTM (tisagenlecleucel) in adult patients with r/r DLBCL, seeking second indication for first-ever FDA approved CAR-T therapy

October 31, 2017

Novartis has announced that the company has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for KymriahTM(tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant (ASCT). In April 2017, Novartis received Breakthrough Therapy designation for r/r DLBCL which, if approved, would be the second indication for Kymriah. In August 2017, Kymriah became the first available chimeric antigen receptor T cell (CAR-T) therapy when it received FDA approval five weeks prior to its PDUFA date and was launched for patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or has relapsed at least twice. Kymriah is a novel immunocellular therapy and a one-time treatment that uses a patient’s own T cells to fight cancer.

AstraZeneca and Incyte enter clinical trial collaboration in early lung cancer

31 October, 2017
AstraZeneca and MedImmune, its global biologics research and development arm, have announced the expansion of their clinical collaboration with Incyte Corporation. As part of the agreement, the companies will evaluate the efficacy and safety of epacadostat, Incyte’s investigational selective IDO1 enzyme inhibitor, in combination with AstraZeneca’s Imfinzi (durvalumab), a human monoclonal antibody directed against PD-L1, compared to Imfinzi alone.

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

PARP Inhibitors 2017

PARP Inhibitors 2017

Poly (ADP-ribose) polymerase (PARP) inhibitors are targeted therapies that are used for multiple indications, most commonly, cancer. PARP aids in cellular growth, regulation and repair of cells.The PARP inhibitor stops the cancer cells being repaired which causes the cells to die thus reducing the tumor growth. Numerous cancer forms are more dependent on PARP than regular cells, making it an attractive target for cancer therapy. Currently they are used to treat ovarian cancer, fallopian tube cancer and peritoneal cancer. These inhibitors are considered as a potential treatment for acute life-threatening diseases, such as stroke and myocardial infarction, along with neurodegenerative diseases. Currently this class of drug is becoming popular which can be deduced from the increased research as seen in the below clinical trial data from past few years.

Good Forecasting: Fortune Telling or Systematic Predictions

Forecasting in the pharmaceutical industry may be viewed as a means of predicting the future, a tool that aids in decision making, a measurement for the uncertainties that lie ahead or a help in planning the next course of action.

No matter the angle, all the perspectives intersect at one point, which is the process of painting an accurate picture of the future, and that’s where many experts may get it wrong.

Top 25 Rheumatology Drugs 2017

Rheumatology drug market is a highly consolidated market with the top ten players accounting for nearly 90% of the market share. The market is also highly competitive with new researches and drug discovery programs by various pharma giants. Abbvie’s Humira tops the list with great margin accounting for more than 30% of the top ten list.  In terms of market presence, J&J steals the show with three drugs in top ten anti-rheumatic drugs, accounting for the larger share (25%) in the top ranking list.

Top 5 Pharmaceutical Companies 2017: Vaccines

Top 10 Pharmaceutical Companies 2017: Vaccines

Vaccines are one of the most cost effective and powerful health interventions available. Billions of people from around the world are successfully being protected from various diseases through these vaccines. In particular, vaccines have helped saving the lives of around three million children each year, and have significantly reduces diseases, disability, and death globally.

Cost of Cancer Drugs: R&D Spending vs Revenues

Cost of Cancer Drugs: R&D Spending vs Revenues

Cost of drugs has been matter of debate in recent years. It is often said that R&D costs to develop new medications are extremely high and this is one of the common arguments used to justify increasing drug prices. According to the estimate by the Tufts Center for the Study of Drug Development, it takes $2.7 billion for a company to bring a single drug to the U.S. market, which is much higher than the previous estimates. The perception of unjustified high costs, especially of anti-cancer drugs has a significant negative impact on research, manufacturers, insurances, and health authorities. Furthermore, groups of patients, regulatory bodies, and policymakers have started raising their voices opposing these high prices.

Top 10 Pharmaceutical Companies 2017: Anti-Virals

Top 10 Pharmaceutical Companies 2017: Anti-Virals

Common types of viral diseases include cold, influenza, chickenpox, HIV/AIDS, viral hepatitis, HPV, viral meningitis, herpes, etc. These diseases are often contagious. When a virus enters the body and starts to multiply, they can spread from one person to another. Some of these viral diseases can be life-threatening, causing complications like pneumonia and diarrhea.

Top Pharma News | October – November 2017 last edit: 2017-11-02T18:36:06+00:00 da Luca

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