Looking back at 2019: Top 10 biopharmaceutical industry news you can’t miss

This article is compiled from Biospace, the original title "top 10 biopharma stories of 2019", by Mark Terry and Alex Keown< br / > recently, Biospace reviewed the top 10 news events in 2019This article compiles them for readers< br / > Biogen's new Alzheimer's drug < br / > in the past few years, with several companies declaring the failure of Alzheimer's drug research and development, Biogen's aducanumab has become the last hope< br / > however, in March 2019, Biogen and its partner, Japanese biopharmaceutical company Eisai (Weicai), announced that they would stop two global phase III clinical trials engage and emerge, and evolveii and prime IB long-term trials for patients with mild cognitive impairment of Alzheimer's diseaseThe reason is that the independent data monitoring committee, after analyzing the effectiveness of these tests, said it was difficult to reach its main end point< br / > on October 22, the two companies announced once again that the high-dose group of aducanumab reached its main end point in the phase III trial of emerge, and some patients in the high-dose group had significant improvement in cognitive and functional indicators including memory, sense of direction and language after receiving the drug treatment, and also showed significant benefits in life activitiesAfter further discussions with the US FDA, the company said it plans to submit an application for approval of biological products for listing in early 2020 and will continue to consult with international market regulators, including Europe and Japan< br / > on December 5, Biogen released all data of the aducanumab trial at the 12th clinical trial of Alzheimer's disease (ctad) conference held in San Diego, USAThe academic and investment community have not been overwhelmed by the news, and most people remain cautiousThey believe that despite some exciting positive data, there are still worrying safety signals and mixed results in the two trials, which may affect whether FDA approves its listing application< br / > aducanumab provides new hope for the treatment of Alzheimer's disease, but the "roller coaster experience" of the new drug continues < br / > keytruda has become the cornerstone of cancer treatment < br / > in June this year, Frank clyburn, chief business officer of MSD, said at the first investors' day meeting in five years that in the near future, keytruda (pabolizumab) will become a basic cancer treatment method"At present, our clinical trials involve 25 different types of cancer Keytruda is changing the way patients are treated today" Although many analysts were worried about the company's over reliance on the product at that time, with the approval of keytruda's indications, clyburn's predictions proved not to be a boast to inflate the stock price< br / > some analysts believe that keytruda is about to replace Humira (lost patent protection in the U.Smarket in 2023) and become the largest drug in the world after 2025In addition, keytruda has obtained more than 20 indications approval since 2014, and with the coming of 2020, keytruda may also obtain more approval, which is expected to obtain more income in the future < br / > the approval of keytruda's indications in China and the United States < br / > (Note: incomplete statistics) < br / > the year of large-scale M & A < br / > M & A is the constant theme of the changing biotechnology industry In 2019, with the occurrence of some M & A cases, the industry pattern has also undergone several large-scale changes < br / > Top 10 deals and acquisitions in 2019 < br / > first of all, it has to be mentioned that in January, BMS announced that it will purchase celgene for us $74 billion The "strong alliance" of the two pharmaceutical giants has created giants in the fields of oncology, hematology, immunology and cardiovascular disease Since the merger, BMS has been approved for marketing, including reblozyl (luspatercept AAMT) developed by celgene and approved by FDA for the treatment of adult patients with β - thalassemia < br / > in June, abbvie announced a $63 billion acquisition of Allergan, a Botox producer At the conclusion of the final deal, the company said that the increase of its existing pipelines and products will immediately bring more benefits to the company's product layout, so as to reduce the current excessive dependence on the heavyweight drug Humira Since the merger, the company will have a number of product franchises in immunology, blood oncology, medical aesthetics, neuroscience, women's health, eye care and virology < br / > although the above two events are the largest M & A cases in 2019, there are still some M & A cases, which are also affecting the changes in the whole biotechnology field For example: the merger of mylan and Upjohn The new company will further expand its market by integrating the highly complementary businesses of the original two companies Many famous brands will appear in the new product pipeline, such as EPI pen, Viagra, Lipitor, Celebrex, etc., and the revenue is expected to reach 20 billion US dollars in 2020 < br / > a $3 billion deal < br / > in January 2019, BMS Howe invested $74 billion to acquire celgene, becoming the biggest deal of the year In September, a $3 billion deal between Sumitomo Dainippon pharma and roivant science also attracted the attention of insiders < br / > Sumitomo Pharmaceutical Co., Ltd of Japan purchased five "vant series" subsidiaries of roivant sciences with us $3 billion in advance At the same time, Sumitomo Pharmaceutical Co., Ltd will also acquire 10% of the shares of roivant and the option to acquire another six enterprises < br / > according to the details of the transaction, Sumitomo Pharmaceutical Co., Ltd will build a new company, which will acquire myovant Sciences (female health and prostate cancer), urovant Sciences (urinary system diseases), enzyvant therapeutics (rare diseases of children), altavant Sciences (rare diseases of respiratory system), And five companies, spirovant Sciences (gene therapy for cystic fibrosis), were included in the unified management Meanwhile, the new company will be temporarily managed and operated by Myrtle Potter, a former Genentech executive and executive chairman of roivant < br / > in addition to the US $3 billion advance payment, Sumitomo Pharmaceutical Co., Ltd of Japan will also need to provide a loan of US $350 million to myovant Sciences for the follow-up research and listing application of releugolix, a clinical candidate drug for the treatment of uterine leiomyoma, and US $200 million to urovant Sciences for the follow-up development of vibegron, a drug for overactive bladder < br / > in the future, if Sumitomo pharmaceutical of Japan exercises the option to continue to acquire other 6 companies, it is expected to obtain the development work of more than 25 kinds of drugs under research between 2020 and 2022, as well as the right to use the proprietary technology platform of roivant, drugome and digital innovation In November 2018, he Jiankui, former associate professor of South University of science and technology, claimed that he Jiankui, who used crispr-cas9 gene editing technology to change the DNA of seven couples' embryos, created the world's first immune AIDS gene editing twins and triggered a gene editing scandal < br / > on March 13, 2019, 18 leading researchers and bioethicists from 7 countries including Zhang Feng and Emmanuelle Carpentier published an article "adopt a moratorium on hereditary genome editing" in the journal Nature, calling for the suspension of all clinical uses of human germ line gene editing on a global scale "A global moratorium does not mean a permanent ban," they said On the contrary, we call for the establishment of an international framework in which countries, while retaining their own decision-making power, voluntarily undertake not to approve any gene editing trial of clinical germlines unless certain conditions are met " < br / > on December 30, 2019, according to Xinhua news agency, the case of "gene editing baby" was publicly adjudicated in the first instance of Nanshan District People's Court of Shenzhen He Jiankui, Zhang Renli, Qin Jinzhou and other three defendants were respectively investigated for criminal responsibility in accordance with the law for their joint illegal implementation of human embryo gene editing and reproductive medical activities aimed at reproduction, which constituted the crime of illegal medical practice < br / > the world's first Ebola vaccine was approved < br / > on November 11, 2019, the European Commission (EC) approved the listing of ervebo (V920), the first Ebola vaccine approved for the market in the world On December 19, the FDA also announced approval of the listing of ervebo, becoming the first FDA approved active immunization for people aged 18 and over to prevent Ebola virus disease (EVD) caused by Ebola Zaire < br / > since August 2018, the second largest Ebola outbreak in the region has occurred in the Democratic Republic of the Congo, during which more than 2000 people died of the disease Before the approval of the vaccine, MSD provided a large number of research preparations for the vaccine in the region and completed more than 250000 person times of vaccination < br / > in addition, Johnson & Johnson's Janssen Pharmaceutical Company is also developing another Ebola vaccine, which has been given to 50000 people in Goma, eastern Congo Compared with Merck's one shot vaccine, Johnson & Johnson vaccine needs to be reinjected 8 weeks after the first shot The vaccine has now submitted two marketing authorization applications (MAA) to the European Drug Administration (EMA) < br / > Purdue applied for bankruptcy < br / > Purdue Pharma, once known for its opiate painkiller Oxycontin, filed for bankruptcy because it was involved in thousands of lawsuits related to the opiate addiction crisis and was unable to pay the legal settlement fee of 10-12 billion US dollars < br / > the local government has publicly accused the company of over Promoting the prescription painkiller Oxycontin and misleading doctors and patients about the excessive risk of the product, thus contributing to the opioid crisis in the United States Up to now, thousands of people in American society have died from overdose of opioids < br / > when Purdue applies for bankruptcy, its assets will be reorganized into a new company, and the board of directors of the new company will be elected by the creditors and approved by the bankruptcy court According to the statement, the new company will produce drugs to treat opioid addiction, such as naloxone and naloxone, at almost zero cost < br / > recall year of carcinogens < br / > recall of drugs due to problems is not uncommon in history However, many drug recalls in 2019 seem to be related to the presence of carcinogens in the pharmaceutical process < br / > since the Valsartan incident of Huahai pharmaceutical in 2018, FDA has been investigating NDMA (N-nitrosodimethylamine) and other nitrosamine impurities in high blood pressure and heart failure drugs (known as ARB), and recommended recalling various types of angiotension II receptor blocker products of many manufacturers Until September 13, 2019, FDA and EMA issued a document saying: not only are antihypertensive drugs contaminated, but related ranitidine drugs (a drug that can inhibit gastric acid secretion, which can be used to treat peptic ulcer and other diseases) It also contains a low level of nitrosamine impurity NDMA So the recall of ranitidine started < br / > after the FDA issued a safety warning, many multinational pharmaceutical companies voluntarily recalled products and suffered impact First, Novartis announced the suspension of Sandoz's marketing of all drugs containing ranitidine, including capsules sold in the United States, involving 26 countries GSK also announced a moratorium on the supply of ranitidine to global markets, including India, and initiated a recall as a precaution pending the outcome of ongoing tests and investigations around the world Other pharmaceutical companies, such as India's Dr Reddy Pharmaceutical Co., Ltd., Sandoz, Canada's Apotex Pharmaceutical Co., Ltd and India's strides Pharmaceutical Co., Ltd., have successively said that their supply of ranitidine drugs in the world or the United States has been suspended