Barbara Obstoj-Cardwell
EditorThe Pharma Letter
Barbara Obstoj-Cardwell is the Managing Editor of The Pharma Letter, which in 2010 acquired the archives of The Pharma Marketletter, a publication that Barbara owned since 1991 and prior to that edited when it was part of IMS Health.
She was also the founding editor of Scrip World Pharmaceutical News, and has an extensive and long-term knowledge of the global pharmaceutical industry and its players.
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Pharmaceutical
Deal-making news last week included Japan’s Takeda Pharmaceutical’s collaboration with ProThera Biologics to develop a novel plasma-based IAIP therapy for acute inflammatory conditions. Research news featured a disappointment for Blueprint Medicines with the release of top-line Phase III results for its gastrointestinal stroma tumor (GIST) drug Ayvakit (avapritinib) that failed. Meantime, Sanofi and partner Regeneron Pharmaceuticals presented data on their trial of the repurposed drug Kevzara as a potential therapy for COVID-19, as well as long-awaited positive data for Gilead Sciences’ anti-viral drug remdesivir in the COVID-19 setting and also from the NIAID study of the drug. Elsewhere, news of the US Food and Drug Administration approval for Neurocrine's Parkinson’s disease drug Ongentys was welcome, but the decision to not launch the drug immediately due to the COVID-19 pandemic, while partly expected, was not. 3 May 2020
Pharmaceutical
Regulatory news last week included two important decisions from the US Food and Drug Administration. First up, Seattle Genetics gained FDA approval for its breast cancer candidate Tukysa (tucatinib). The other was FDA clearance for Incyte’s Pemazyre (pemigatinib) as a treatment for metastatic cholangiocarcinoma. Clinical trial news of note included Switzerland-based Idorsia scoring a goal with positive Phase III results with its investigational insomnia treatment daridorexant, and AstraZeneca on Friday presented new data on its Lynparza in the treatment of prostate cancer. 26 April 2020
Pharmaceutical
Among last week’s news of note, Alnylam seems to have had a windfall in terms of a deal with Blackstone that, in exchange for royalty rights on inclisiran, a potential treatment for heterozygous familial hypercholesterolemia, it will get $2 billion funding. On the regulatory front, AstraZeneca gained US Food and Drug Administration approval for its rare disease drug Koselugo (selumetinib). Standing out among a significant amount of novel coronavirus news, was the planned collaboration of two ‘Big Pharmas’ – GlaxoSmithKline and Sanofi – to work on a potential COVID-19 vaccine. Also, although reports from Chinese trials on Gilead Sciences’ candidate remdesivir were disappointing, the company’s own studies, which have yet to report officially, anecdotally, show more promise. 19 April 2020
Pharmaceutical
As to be expected, the novel coronavirus continued to dominate the news last week, including Gilead Sciences’ decision to ramp up production and research of its COVID-19 candidate remdesivir, as well as gifting 1.5 million doses. Also, global plasma leaders, including Takeda and CSL Behring, are collaborating on a possible hyperimmune therapy for COVID-19. Additionally, GlaxoSmithKline and Vir Biotechnology announced that their collaboration would prioritize coronavirus drugs, notably VIR-7831 and VIR-7832. Elsewhere, Millendo Therapeutics suffered a blow on Monday, when its rare disease drug livoletide failed to meet Phase IIb goals and leading to the company terminating the PWS program. 12 April 2020
Pharmaceutical
Much as COVID-19 was the focus of news last week, other things were happening too. Among these, Danish CNS specialist Lundbeck suffered a couple of signification setbacks, first with Tourette syndrome candidate Lu AG06466, and then even worse, with Parkinson’s hopeful foliglurax. There was better news for Bayer and Merck & Co, whose heart failure drug vericiguat saw positive results presented at the American College of Cardiology’s meeting. On the legal front, there was a major disappointment for Amarin, when a US court declared that the company’s patents on its fish oil-based cardiovascular drug Vascepa were not valid. Deal-making news included Daiichi Sankyo acquiring gene therapy manufacturing technology from Ultragenyx, signalling an interest in expanding the company’s focus. Also, Fate Therapeutics agreed a deal with Johnson & Johnson for rights to its iPSC platform. 5 April 2020
Pharmaceutical
Deal-making news last week featured Bayer’s announcement on Monday that it is teaming up with India’s Curadev to use the latter’s STING antagonists to develop therapies across a range of indications. Also, Silence Therapeutics has inked a deal with AstraZeneca worth up to $400 million on siRNA therapeutics, including SLB360. Among research news, Novavax presented new data on its flu vaccine candidate NanoFlu that compared it with Sanofi’s Fluzone. Regulatory news included Food and Drug Administration approval for Bristol-Myers Squibb’s multiple sclerosis drug Zeposia. Also, in an unusual move, Gilead Sciences asked the FDA to rescind Orphan Drug designation for its anti-viral candidate remdesivir, which is now been investigating as a possible COVID-19 treatment. 29 March 2020
Pharmaceutical
Coronavirus again dominated the news last week, as Germany’s CureVac gained a lot of attention on talk that the US government was planning to acquire its COVID-10 program. Another German company, BioNTech, announced solid progress on its COVID-19 vaccine program along with a new alliance with Fosun Pharma. US biotech Moderna shot up on Monday, on news that its coronavirus vaccine mRNA-1273 had seen its first patient dosed in a National Institutes of Health study. There was also a fair amount of excitement after Chinese doctors declared that Fujifilm Toyama’s Avigan was effective in COVID-19. Meantime, Novo Nordisk suffered a setback in a trial of concizumab in hemophilia. 22 March 2020
Pharmaceutical
Apart from the novel coronavirus COVID-19 totally dominating the news all last week, there were other things of note. On the research front, last Monday, Bristol-Myers Squibb released disappointing Phase III results for the combination of Empliciti, Revlimid and dexamethasone in untreated multiple myeloma. In another flop in ovarian cancer, AstraZeneca and Merck & Co released new data on cediranib and Lynparza that failed its Phase III endpoint. Kala Pharmaceuticals last week presented positive Phase III results for its dry eye disease drug candidate KPI-121, or Eysuvis. Elsewhere, India’s Zydus Cadila gained domestic approval for its Lipaglyn as a treatment for non-alcoholic steatohepatitis (NASH). 14 March 2020
Pharmaceutical
US biotech Gilead Sciences stepped further into the immuno-oncology arena last week, announcing a $4.9 billion acquisition of Forty Seven Inc and its candidate magrolimab. On the regulatory front, Sanofi received US Food and Drug Administration for its multiple sclerosis drug Sarclisa isatuximab on Monday, some eight weeks earlier than expected. There was much reporting of developments on the novel coronavirus COVID-19, with Japan’s Takeda announcing a different approach to tackling the epidemic with plasma-based therapies via a candidate vaccine dubbed TAK-888. Also regarding research, there was disappointment for AstraZeneca, when its immune-oncology drug Imfinzi failed endpoints in a Phase III bladder cancer drug. 8 March 2020
Pharmaceutical
US regulatory approvals featured significantly in last week’s news, with Esperion Therapeutics receiving Food and Drug Administration clearance for its cholesterol lowering drug Nexletol, marking the company’s first approval. Baudax Bio received FDA approval for its non-opioid pain drug Anjeso and the agency granted approval for Lundbeck’s Vyepti, the first intravenous treatment for migraine. In M&A news, Takeda exercized its option to acquire PvP Biologics, while deals included Sangamo’s collaboration with Biogen for its zinc finger protein technology and Alzheimer’s and Parkinson’s disease. 1 March 2020
Pharmaceutical
Last week’s news featured quite a lot relating to the ongoing novel coronavirus (COVID-19) situation, including that Sanofi’s vaccine division joining the band of drugmakers linking with the USA’s BARDA in attempts to develop a vaccine against COVID-19. Elsewhere on the research front, Incyte reported a second positive study for its Jakafi (ruxolitinib) in dermatitis, but Teva Pharmaceutical Industries posted disappointing Phase II/III results for Austedo in Tourette’s syndrome. Regulatory news included Pfizer gaining European approval for its Vyndaqel in the rare condition ATTRR-CM, and BioMarin announced the US Food and Drug Administration had accepted its gene therapy ValRox for priority review. 23 February 2020
Pharmaceutical
Last week’s news included further disappointment for the Alzheimer’s community, with Eli Lilly’s solanezumab and Roche’s gantenerumab failing in their latest trials. There was also disappointment for Biohaven Pharmaceuticals’ troriluzole for generalized anxiety disorder (GAD). On a more positive note, US biotech Moderna saw a sharp rise it its market cap after it announced a positive development for its coronavirus vaccine. Regulatory news included US Food and Drug Administration acceptance for priority review of Bristol-Myers Squibb’s immune-oncology candidate lisocabtagene maraleucel (liso-cel). Also, Japan’s Eisai was obliged to withdraw its weight-loss drug Belviq from the US market. 16 February 2020
Biosimilars
Last week’s news included Bristol-Myers Squibb deciding to pull its application with the European Medicines Agency for the combination of its top-selling drug Opdivo with Yervoy for certain cancer patients. US biotech Biogen had a boost last Wednesday when it prevailed in a patent dispute with Mylan over multiple sclerosis drug Tecfidera. On the research front and in the face of the ever-increasing impact of the coronavirus epidemic, Gilead Sciences joined the fight with its investigational antiviral remdesivir and entering trials in China, and GlaxoSmithKline linked up with the Coalition for Epidemic Preparedness Innovations. Last week also saw the US Food and Drug Administration and the Federal Trade Commission announce a cooperation on making biosimilars more accessible. And, along with its 2019 financial results, US pharma giant Merck & Co said it plans to spin out its established products into a new company. 9 February 2020
Pharmaceutical
As part of competition requirements to consummate its $63 billion acquisition of Allergan, AbbVie has divested its gastrointestinal drug candidate brazikumab and cystic fibrosis drug Zenpep. Among research news, Acceleron saw its shares leap after it announced strong Phase III results for its pulmonary arterial hypertension drug sotatercept, and Incyte released encouraging top-line results from a Phase III study od ruxolitinib in atopic dermatitis. Regulatory news included, on Friday, Aimmune Therapeutics becoming the first company to gain US Food and Drug Administration approval for a peanut allergy treatment, to be marketed under the brand name Palforzia. 2 February 2020
Pharmaceutical
Last week’s regulatory news included European approval for Swiss pharma giant Novartis’ Mayzent, its potential blockbuster for the treatment of a particular form of multiple sclerosis. Important clinical trial results featured big, with China’s BeiGene reporting positive new data on its lung cancer candidate tislelizumab and Swiss giant Roche releasing positive results from the FIREFISH study of its spinal muscular atrophy agent risdiplam. Meantime, French drugmaker Ipsen on Friday said it was pausing dosing of patients in a Phase III study of palovarotene for a rare bone disease. 26 January 2020
Pharmaceutical
Licensing featured in the news last week, with Germany’s MorphoSys announcing a deal with USA-based Incyte to commercialize its B-cell malignancies candidate tafasitamab, and Biogen taking over an early-stage drug from Pfizer - PF-05251749 - which has potential for treating sleep disorders associated with Alzheimer’s and Parkinson’s disease. Also, UK-based Adaptimmune entered into a lucrative collaboration with Japan’s Astellas Pharma on cancer research. Elsewhere, Swiss giant Novartis’ novel arrangement with the UK’s National Health Service for access to its cardiovascular drug inclisiran attracted a fair amount of attention. On the M&A front, German biotech BioNTech said last Thursday it was buying USA-based Neon Therapeutics to boost its T-cell pipeline. 19 January 2020
Pharmaceutical
Among notable research news last week, Merck KGaA and Pfizer released new Phase III data for Bavencio in urothelial carcinoma, and Apellis Pharma reported strong results for its rare blood disorder candidate pegcetacoplan, seemingly besting Alexion’s Solaris. Dealing-making news featured Japan’s Chugai out-licensing its investigational cancer drug CKI27 to Verastem. Elsewhere, Blueprint Medicines gained earlier than expected Food and Drug Administration approval for Ayvakit (avapritinib for the treatment of gastrointestinal stromal tumors, and Eli Lilly announced a $1.1 billion takeover of dermatology specialist Dermira, along with its lead investigational candidate lebrikizumab. 12 January 2020
Pharmaceutical
Among regulatory news of note, China’s BeiGene gained its first drug approval on its domestic market, that of tislelizumab for Hodgkin’s lymphoma. M&A events saw Swiss pharma giant Roche finally gain clearance from competition authorities to close its $4.3 billion acquisition of gene therapy developed Spark Therapeutics. On the research front, Axsome Therapeutics last week released positive results for its migraine drug candidate AXS-07. It also has an interesting depression drug candidate in development. But there was disappointment for Incyte with the failure of its Phase III itacitinib trial in graft versus host disease. 5 January 2020
Pharmaceutical
Company and product acquisitions featured in the news last week, first with Japan’s Astellas Pharma announcing a $3 billion bid for US biotech Audentes Therapeutics, marking a major move into gene therapy. Also, Canada’s Xenon Pharmaceuticals on Monday entered a licensing deal with Neurocrine Biosciences for its epilepsy candidate XEN901. An additional Food and Drug Administration indication approval for Roche’s Tecentriq in lung cancer sets up immune-oncology competition with Merck & Co’s Keytruda. On the research front, there was disappointment on Thursday for Sage Therapeutics, whose depression drug SAGE-217 failed in a Phase III trial, and Biogen presented new data on two studies of its previously shelved Alzheimer’s disease candidate aducanumab. 8 December 2019
Pharmaceutical
Swiss pharma giant Novartis set the scene in M&A news, announcing a $9.7 billion acquisition of US biotech firm The Medicines Company and its cholesterol-lowerer inclisiran. Clinical trials news featured ChemoCentryx, which saw its shares triple on Tuesday after reporting strong Phase III results with its ANCA vasculitis drug candidate avacopan. Last week also saw a second sickle cell disease drug approval from the US Food and Drug Administration, this time Global Blood Therapeutics’ Oxbryta (voxelotor). Meanwhile, Hutchison China MediTech, also known as Chi-Med, gained approval and price listing for its Elunate for advanced colorectal cancer in China. 1 December 2019
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