Boehringer Ingelheim and Dicerna Announce Collaboration to Develop Novel Treatments for Chronic Liver Diseases including Nonalcoholic Steatohepatitis (NASH)
November 2, 2017
Boehringer Ingelheim and Dicerna Pharmaceuticals, a leading developer of investigational RNA interference (RNAi) therapeutics, have announced a research collaboration and license agreement to discover and develop novel GalXC™ RNAi therapeutics for the treatment of chronic liver diseases. The partnership will initially focus on nonalcoholic steatohepatitis (NASH), a devastating, chronic liver disease for which there is no approved treatment option.
Merck KGaA Presents Late Breaking Clinical Data from Phase II Trial of Sprifermin for Osteoarthritis Disease Modification
November 4, 2017
Merck KGaA, a leading science and technology company, has announced results of the two-year primary analysis of FORWARD, a five-year, multicenter Phase II study of sprifermin in patients with knee OA. The study of 549 patients met its primary endpoint, demonstrating statistically- significant, dose-dependent increases in MRI total femorotibial joint cartilage thickness from baseline in the two sprifermin groups receiving the highest doses as compared with the placebo group after the two-year treatment period.
New Analysis Shows Rheumatoid Arthritis Patients Treated with Baricitinib Reported Greater Improvements in Pain Compared to Adalimumab or Placebo
November 5, 2017
Eli Lilly and Company and Incyte Corporation have announced that patients with moderate-to-severe rheumatoid arthritis (RA) treated with baricitinib reported greater improvements in pain control when compared to Humira®* (adalimumab) or placebo.
New Phase 2 Data Show Treatment with TREMFYA (Guselkumab) Improved Psoriatic Arthritis Symptoms Through One year
November 7, 2017
Janssen Research & Development, LLC (Janssen) announced today longer-term results from a Phase 2 study investigating TREMFYA® (guselkumab), the first selective anti-interleukin (IL)-23 monoclonal antibody to show positive results in the treatment of active psoriatic arthritis. According to findings presented at the 2017 ACR/ARHP Annual Meeting, more than 70 percent of patients receiving TREMFYA® 100 mg subcutaneous injections achieved at least a 20 percent improvement in signs and symptoms of disease (ACR 20) using observed data at week 56.
Novartis announces study data demonstrating Cosentyx® reduced signs and symptoms of psoriatic arthritis while inhibiting progression of joint structural damage
November 7, 2017
Novartis has announced results from the FUTURE 5 study showing Cosentyx® (secukinumab) reduced the signs and symptoms of psoriatic arthritis (PsA) while significantly inhibiting the progression of joint structural damage in PsA patients compared to placebo at 24 weeks.
Opdivo Plus Yervoy Combination Delivered Overall Survival Benefit Across PD-L1 Expression Levels in Intermediate- and Poor-Risk Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma
November 7, 2017
Bristol-Myers Squibb Company has announced results from a new exploratory analysis of the phase 3 CheckMate -214 trial evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) versus the standard of care, sunitinib, in intermediate- and poor-risk patients with previously untreated advanced or metastatic renal cell carcinoma (RCC). In an exploratory analysis of PD-L1 expression subgroups, an overall survival (OS) advantage was seen with the Opdivo plus Yervoy combination over sunitinib in both the PD-L1 expression level <1% [HR= 0.73, (CI: 95% 0.56 to 0.96)] and ?1% subgroups [HR= 0.45 (CI: 95% 0.29 to 0.71)]. The median overall survival (OS) was not reached for the Opdivo plus Yervoy combination or sunitinib for those with PD-L1 levels < 1%, and for patients with PD-L1 expression levels ?1%, the median OS was not reached for the combination and was 19.6 months for sunitinib. The safety profile of Opdivo plus Yervoy was consistent with that of previous reports.
Novartis reports positive results from Phase III trial of Kisqali® (ribociclib) combination therapy in premenopausal women with HR+/HER2- advanced or metastatic breast cancer
November 8, 2017
Novartis has announced positive topline results from the global MONALEESA-7 trial, the second Phase III trial of Kisqali® (ribociclib) in advanced or metastatic breast cancer. The MONALEESA-7 trial met its primary endpoint of progression-free survival (PFS) in premenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer.
Seattle Genetics Announces FDA Approval of ADCETRIS® (Brentuximab Vedotin) for Primary Cutaneous Anaplastic Large Cell Lymphoma (pcALCL) and CD30-Expressing Mycosis Fungoides (MF)
November 9, 2017
Seattle Genetics, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved ADCETRIS (brentuximab vedotin) for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) and CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy. Primary cutaneous ALCL and MF are the most common subtypes of cutaneous T-cell lymphoma (CTCL). The approval is based on data from the phase 3 ALCANZA trial and two phase 2 investigator-sponsored trials.
Merck Receives FDA Approval of PREVYMIS™ (letermovir) for Prevention of Cytomegalovirus (CMV) Infection and Disease in Adult Allogeneic Stem Cell Transplant Patients
November 9, 2017
Merck & Co., Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved PREVYMIS™ (letermovir) once-daily tablets for oral use and injection for intravenous infusion. PREVYMIS is indicated for prophylaxis (prevention) of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).
Encouraging Response Observed with Opdivo (nivolumab) Plus Investigational IDO1 Inhibitor, BMS-986205, in Heavily Pre-Treated Patients with Advanced Cancers in Phase 1/2a Study CA017-003
November 10, 2017
Bristol-Myers Squibb Company has announced updated results for Opdivo (nivolumab) plus BMS-986205, a selective, once-daily oral indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor from the ongoing Phase 1/2a dose escalation and expansion study, CA017-003. In the dose escalation phase, the maximum tolerated dose (primary endpoint) of BMS-986205 in combination with Opdivo was 200 mg. Based on safety and pharmacodynamic data, the recommended dose for further study was determined to be 100 mg. In the dose expansion phase, findings for anti-tumor activity (primary endpoint) were reported in two cohorts – heavily pre-treated bladder (n=25) and cervical cancer patients (n=22). In the bladder cancer cohort, the objective response rate (ORR) and disease control rate (DCR) were 32% and 44%, respectively. In the cervical cancer cohort, the ORR was 14% and DCR was 64%.
Amgen And Allergan Receive Positive CHMP Opinion for ABP 215 (Biosimilar Bevacizumab) For the Treatment of Certain Types of Cancer
November 10, 2017
Amgen and Allergan plc. have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the Marketing Authorization of ABP 215, a biosimilar to Avastin®(bevacizumab). ABP 215 has been recommended for approval for the treatment of certain types of cancer, including in combination with fluoropyrimidine-based chemotherapy for metastatic carcinoma of the colon or rectum; in combination with paclitaxel for metastatic breast cancer; in combination with platinum-based chemotherapy for unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC); in combination with erlotinib for unresectable advanced, metastatic or recurrent non-squamous NSCLC; in combination with interferon alfa-2a for advanced and/or metastatic renal cell cancer; in combination with carboplatin and paclitaxel, carboplatin and gemcitabine, and paclitaxel, topotecan, or pegylated liposomal doxorubicin for advanced, platinum-sensitive, or platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer; and in combination with paclitaxel and cisplatin, or alternatively, paclitaxel and topotecan for persistent, recurrent, or metastatic carcinoma of the cervix.
First Data for NKTR-214 in Combination with OPDIVO® (nivolumab) for Patients with Stage IV Melanoma, Renal Cell Carcinoma and Non-Small Cell Lung Cancers, Including Patients with PD-L1 Negative Status
November 11, 2017
Nektar Therapeutics and Bristol-Myers Squibb have announced the first presentation of data from the PIVOT-02 Phase 1/2 Study, which is designed to evaluate the combination of Bristol-Myers Squibb’s Opdivo (nivolumab) with Nektar’s investigational medicine, NKTR-214. The initial results presented at the 2017 Society for Immunotherapy of Cancer (SITC) Annual Meeting reported both safety and efficacy data for patients enrolled in the dose-escalation phase of the trial. The initial findings revealed the potential benefit of the combination of Opdivo and NKTR-214 across several tumor types.
Bayer and Loxo Oncology to develop and commercialize two novel oncology therapies selectively targeting
November 14, 2017
Bayer has announced that the company has entered into an exclusive global collaboration with Loxo Oncology, Inc., a biopharmaceutical company based in Stamford, Connecticut, US, (NASDAQ: LOXO) for the development and commercialization of larotrectinib (LOXO-101) and LOXO-195. Both compounds are being investigated in global studies for the treatment of patients with cancers harboring tropomyosin receptor kinase (TRK) gene fusions, which are genetic alterations across a wide range of tumors resulting in uncontrolled TRK signaling and tumor growth.
November 14, 2017
AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration (FDA) has approved Fasenra (benralizumab) for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.
Faslodex receives US FDA approval for the treatment of advanced breast cancer in combination with abemaciclib
November 15, 2017
AstraZeneca has announced that the US Food and Drug Administration (FDA) has approved a new indication for Faslodex(fulvestrant), expanding the indication to include use with abemaciclib, a CDK4/6 inhibitor, for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer (MBC) in women with disease progression after endocrine therapy.
November 16, 2017
Roche has announced that the US Food and Drug Administration (FDA) has approved Hemlibra® (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with haemophilia A with factor VIII inhibitors. Nearly one in three people with severe haemophilia A can develop inhibitors to factor VIII replacement therapies, putting them at greater risk for life-threatening bleeds or repeated bleeds that can cause long-term joint damage. In two of the largest pivotal clinical studies for people with haemophilia A with inhibitors, Hemlibra was shown to substantially reduce bleeds in adults and children.
Pfizer receives FDA approval for Sutent® (sunitinib malate) as first and only adjuvant treatment for adult patients at high risk of recurrent renal cell carcinoma
November 16, 2017
Pfizer Inc. has announced that the U.S. Food and Drug Administration has approved a new indication expanding the use of SUTENT® (sunitinib malate) to include the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) following nephrectomy (surgical removal of the cancerous kidney). The approval was based on results from the S-TRAC trial that demonstrated a significant reduction in the risk of a disease-free survival (DFS) event (defined as the interval between randomization and tumor recurrence, or secondary primary cancer or death from any cause) for patients at high risk of RCC recurrence who received SUTENT compared to placebo in the adjuvant setting.
Celgene Corporation and bluebird bio Announce bb2121 Anti-BCMA CAR-T Cell Therapy Has Been Granted Breakthrough Therapy Designation from FDA and Prime Eligibility from EMA for Relapsed and Refractory Multiple Myeloma
November 16, 2017
Celgene Corporation and bluebird bio, Inc. have announced that bb2121, a chimeric antigen receptor T-cell (CAR-T) therapy targeting b-cell maturation antigen (BCMA) in previously treated patients with multiple myeloma, has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) and PRIority MEdicines (PRIME) eligibility by the European Medicines Agency (EMA).
November 17, 2017
Roche has announced that the US Food and Drug Administration (FDA) approved Gazyva® (obinutuzumab) in combination with chemotherapy, followed by Gazyva alone in those who responded, for people with previously untreated advanced follicular lymphoma (stage II bulky, III or IV). The approval is based on results from the phase III GALLIUM study, which showed superior progression-free survival (PFS) for patients who received this Gazyva-based regimen compared with those who received a Rituxan® (rituximab)-based regimen as an initial (first-line) therapy. Follicular lymphoma, the most common slow-growing (indolent) form of non-Hodgkin lymphoma (NHL), is incurable and becomes harder to treat each time it returns.
Phase III IMpower150 study showed Roche’s TECENTRIQ (atezolizumab) and Avastin (bevacizumab) plus chemotherapy significantly reduced the risk of disease worsening or death in the initial treatment of people with a type of advanced lung cancer
November 20, 2017
Roche has announced that the Phase III IMpower150 study met its co-primary endpoint of progression-free survival (PFS) and demonstrated that the combination of TECENTRIQ® (atezolizumab) and Avastin® (bevacizumab) plus chemotherapy (paclitaxel and carboplatin) provided a statistically significant and clinically meaningful reduction in the risk of disease worsening or death (PFS) compared to Avastin plus chemotherapy in the first-line treatment of people with advanced non-squamous non-small cell lung cancer (NSCLC). Initial observations for the co-primary endpoint of overall survival (OS) are encouraging.
Juluca® (dolutegravir and rilpivirine) approved in US as first 2-drug regimen, once-daily, single pill – a complete regimen for the maintenance treatment of virologically suppressed HIV-1 infection
November 21, 2017
ViiV Healthcare, the global specialist HIV company, majority owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) has approved Juluca®, indicated as a complete regimen for the maintenance treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral (ART) regimen for at least six months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Juluca.
Novartis’ Ultibro® Breezhaler® significantly improved COPD patients’ lung function after direct switch from Seretide®
November 27, 2017
Novartis has announced positive results from the FLASH study examining the safety and efficacy of directly switching chronic obstructive pulmonary disease (COPD) patients from Seretide®(salmeterol/fluticasone) 50/500 mcg to Ultibro® Breezhaler®(indacaterol/glycopyrronium) 110/50 mcg. The study met the primary endpoint demonstrating that switching patients to Ultibro Breezhaler resulted in significantly improved lung function (trough FEV1).
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Pharma invests heavily in bringing new therapeutic drugs to the doctors and their patients to help them manage, treat and sometimes even cure their diseases. These new agents are undergoing expensive phase 1, 2, and 3 clinical trials to establish that these drugs (or devices) are safe, tolerable, efficacious, more convenient and/or better (or no worse) than the current standard of care (SOC). Pharma companies want to make sure that what they are developing is actually seen as being a valuable addition to the doctors, their patients and their disease. And also, to understand if the market is ready for this new product, and if it is not yet, what needs to be done and put in place in the (near) future in order to have a successful launch of the drug. Pharma companies therefore ask advice from local key opinion leaders (KOLs) during an advisory board (ad board) meeting. As a Medical Science Liaison (MSL) you can (and should) be involved in this process.Top Pharma News | November – December 2017 last edit: 2017-12-03T19:42:29+00:00 da