01 May 2017
AstraZeneca and its global biologics research and development arm, MedImmune, have announced that the US Food and Drug Administration (FDA) has granted accelerated approval to Imfinzi (durvalumab). Imfinzi is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery. Imfinzi is approved under the FDA’s accelerated approval pathway, based on tumour response rate and durability of response.
May 3, 2017
Pfizer Inc. has announced that the United States Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for XELJANZ® (tofacitinib citrate) 5 mg twice daily (BID) for the treatment of adult patients with active psoriatic arthritis (PsA). A separate sNDA was also accepted for XELJANZ XR® (tofacitinib citrate) extended release 11 mg once daily use in PsA.
May 5, 2017
Merck has announced that the European Commission has approved KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) and brentuximab vedotin (BV), or who are transplant-ineligible and have failed BV. The approval allows marketing of KEYTRUDA in all 28 EU member states plus Iceland, Lichtenstein and Norway, at the approved dose of 200 mg every three weeks until disease progression or unacceptable toxicity.
May 9, 2017
EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, and Pfizer Inc., have announced that the US Food and Drug Administration (FDA) has approved BAVENCIO® (avelumab) Injection for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. BAVENCIO was previously granted accelerated approval from the FDA for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC).
May 23, 2017
Roche has announced that the U.S. Food and Drug Administration (FDA) has approved Actemra®/RoActemra® (tocilizumab) subcutaneous injection for the treatment of GCA, a chronic and severe autoimmune condition. Actemra/RoActemra is the first therapy approved by the FDA for the treatment of adult patients with GCA. This is the sixth FDA approval for Actemra/RoActemra since the medicine was launched in 2010.
May 30, 2017
Merck has announced that the U.S. Food and Drug Administration (FDA) has approved ISENTRESS® HD, a new 1200 mg once-daily dose of the company’s integrase inhibitor, ISENTRESS® (raltegravir), to be administered orally as two 600 mg film-coated tablets with or without food, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in adults, and pediatric patients weighing at least 40 kg, who are treatment-naïve or whose virus has been suppressed on an initial regimen of ISENTRESS 400 mg given twice daily.
Jun 01, 2017
Janssen Sciences Ireland UC has announced that ViiV Healthcare has made regulatory submissions to both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for a single-tablet, two-drug regimen of dolutegravir (ViiV Healthcare) and rilpivirine (Janssen). If approved, this will be the first two-drug regimen for the maintenance treatment of HIV-1 infection and will offer those living with HIV who are virally suppressed the option to switch to a regimen which does not include a nucleotide reverse transcriptase inhibitor (NRTI).
June 05, 2017
Novartis has announced that it has entered into a clinical research collaboration in which Bristol-Myers Squibb will investigate the safety, tolerability, and efficacy of Mekinist (trametinib) in combination with Opdivo (nivolumab) and Opdivo + Yervoy (ipilimumab) regimen as a potential treatment option for metastatic colorectal cancer in patients with microsatellite stable tumors where the tumors are proficient in mismatch repair (MSS mCRC pMMR).
June 05, 2017
Novartis has announced a first-of-its-kind collaboration with IBM Watson Health on an initiative to optimize cancer care and improve patient outcomes. The two companies will collaborate to explore development of a cognitive solution that uses real-world data and advanced analytical techniques with the aim to provide better insights on the expected outcomes of breast cancer treatment options.
June 8, 2017
Bristol-Myers Squibb Company has announced the availability of a new FDA-approved subcutaneous (SC) ORENCIA administration option for use in patients 2 years of age and older with moderately to severely active polyarticular Juvenile Idiopathic Arthritis (JIA). The new prefilled syringe offers physicians, patients, and caregivers of these patients the option of ORENCIA treatment that can be administered at home. In 2008, ORENCIA IV was the first FDA-approved IV biologic for use in patients 6 years of age and older with moderately to severely active polyarticular JIA.
Jun 16, 2017
Johnson & Johnson has announced the completion of the acquisition of Actelion Ltd for a total purchase price of approximately $30 billion in cash. The acquisition was completed through an all-cash public tender offer by Johnson & Johnson’s Swiss subsidiary, Janssen Holding GmbH, to acquire all publicly held shares of Actelion Ltd for $280 per share, payable in U.S. dollars. Actelion will now become part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
June 16, 2017
Bristol-Myers Squibb Company and SK Biotek Co., Ltd. have announced that the companies have signed a definitive purchase agreement to sell Bristol-Myers Squibb’s small molecule active pharmaceutical ingredient manufacturing facility in Swords, Ireland, to SK Biotek, a wholly-owned subsidiary of SK Holdings, based in Seoul, South Korea. The companies intend to complete the deal by the fourth quarter 2017, at which time SK Biotek will continue to manufacture the current portfolio of small molecule pharmaceutical products at the site.
June 23, 2017
Roche has announced that new data from additional analyses of the pivotal phase III GALLIUM study in people with previously untreated follicular lymphoma will be presented at the 22nd European Hematology Association (EHA) annual congress, 22-25 June, in Madrid, Spain. The data confirmed that the improvement in progression-free survival (PFS) with Gazyva®/Gazyvaro® (obinutuzumab)-based treatment over MabThera®/Rituxan®(rituximab)-based treatment was sustained in an updated analysis with a further six months of follow-up, irrespective of chemotherapy regimen.
23 June 2017
AstraZeneca has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorisation of Faslodex (fulvestrant) for the treatment of hormone receptor-positive (HR+), locally-advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy, or with disease relapse on or after adjuvant anti-oestrogen therapy, or disease progression on anti-oestrogen therapy.
June 23, 2017
AbbVie has announced that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion recommending marketing authorization of MAVIRET™ (glecaprevir/pibrentasvir), an investigational, pan-genotypic treatment for adults with chronic hepatitis C virus (HCV) infection. If approved, MAVIRET will be a once-daily, ribavirin-free, 8-week option for patients without cirrhosis and who are new to treatment across all genotypes (GT1-6), who comprise the majority of people living with HCV.