"Pharmaceutical Express" Opdivo combination therapy by the FDA priority review of Tinker Bell Express drug financing of $1 billion

October 20, 2020 / Pharmaceutical Information At a Glance: Keystone Pharmaceuticals PD-L1 Antibodies Are Eligible for FDA Orphan Drugs; Tinker Bell Express Raises $1 Billion; AstraZenece Two Drugs Approved by CHMP; Opdivo Combination Therapy Approved by FDA Priority Review; Daily fresh medicine news, speed reading society and you pay attention to! Part 1 Policy Brief Gansu issued the third batch of national collection and registration network declaration work notice October 19, Gansu Province issued "on the third batch of state-organized drug centralized procurement of related drugs registration network declaration work notice."
notice shows that the relevant enterprises within the scope of the declaration shall submit the report materials within the prescribed time, which shall be reviewed by the Provincial Public Resources Trading Bureau, and the results shall be hung up or suspended (cancelled) after no objection has been made public.
not declare or declare as required, do suspend or cancel the network registration processing.
declaration time: October 19, 2020 to October 31, 2020 (Gansu Provincial Health Insurance Bureau) Anhui Province requires the province to adhere to the "two-vote system" October 19, Anhui Provincial Health Insurance Bureau and other relevant departments issued "Anhui Province public medical institutions clinical commonly used drugs centralized belt procurement negotiation bargaining implementation plan."
Implementation Programme shows that the supply of medicines should be guaranteed.
adhere to the "two-vote system" and encourage the "one-vote system".
(Anhui Provincial Health Insurance Bureau) Part 2 production by observation Tinker Bell Express announced the completion of 1 billion yuan B-plus round of financing today, Dingding Express announced the completion of 1 billion yuan of B-plus round of financing, Taikang, Haier Medical, Longmen Investment in cooperation with China Merchants International China Merchants Telecom Fund, China National Pharmaceutical Co., D.C., SoftBank China and other old shareholders to jointly invest.
(Sina Pharmaceutical News) East China Pharmaceuticals and ImmunoGen signed an exclusive clinical development and commercialization agreement with ImmunoGen today, East China Pharmaceuticals announced that its wholly-owned subsidiary China-U.S. East China reached an exclusive clinical development and commercialization agreement with U.S. ImmunoGen on October 19, 2020.
East China Pharmaceuticals acquired the exclusive clinical development and commercialization interest in Mirvetuximab Soravtansine in Greater China for ImmunoGen U.S. Clinical Phase III.
(Sina Pharmaceutical News) Four-Ring Pharmaceutical Investment Time Capital Life Science and Technology Phase I Fund Today, Four Rings Pharmaceutical Holdings Group Co., Ltd. announced its participation in the Investment Phase I Fund of Ji-ring Capital Life Technology Investment Phase I Fund.
(The Associated Press) Asahi and Weijian Pharmaceuticals reached a strategic cooperation on the tablets today, Asahi and Hong Kong Health Pharmaceuticals announced that the two sides reached a strategic cooperation: from August 10, 2020, Asahi into its important products, Follett ® (commonly known as the tablets) of the licensee and manufacturer, the ® in Chinese mainland commercial rights granted to the Hong Kong Viking Pharmaceutical Group.
(American News Agency) Hengrui nominated Liao as the company's deputy general manager october 19, Hengrui announced that the company's 8th board of directors at the 7th meeting of the resolution, to consider the adoption of the "on the nomination of Mr. Liao Cheng as the company's deputy general manager of the bill", according to the company's business development needs, is nominated to hire Liao as the company's deputy general manager.
(Sina Pharmaceutical News) Qilu Pharmaceuticals won the exclusive interest of "first-in-class" in China on October 19, Quantum Genomics announced that it has signed an exclusive license and cooperation agreement with Qilu Pharmaceuticals.
terms of the agreement, Qilu Pharmaceuticals will receive exclusive commercial rights to the former potential hypertension treatment firibastat in China, including Hong Kong and Macau.
Quantum will receive up to $50 million in advance and milestone payments, plus double-digit sales royalties.
(Pharmaceutical Mission) Pharmaceuticals Ming Juno through the HONG Kong Stock Exchange hearing relma-cel priority review and breakthrough treatment varieties October 18, the HKEx website public information shows that pharmaceutical Ming Juno (Kaiman) Co., Ltd. IPO application has been heard by the Hong Kong Stock Exchange.
company's new drug for anti-CD19 CAR-T therapy, relma-cel, was approved as a priority review by NMPA in September for third-line treatment of diffuse large B-cell lymphoma.
addition, relma-cel was included in the NMPA breakthrough treatment in September for the treatment of fable lymphoma.
(Pharma Mission) Part 3 Drug News AstraZeneta was approved by CHMP on October 19, AstraZenecon announced that Forxiga Extended Adaptive Disorders and Trixeo Aerosphere have been recommended by CHMP for the treatment of adult patients with symptomatic chronic heart failure and adult patients with moderate to severe chronic obstructive pulmonary disease, respectively.
(Sina Pharmaceutical News) Roche member Genentek recently signed an agreement with Genesis Therapeutics to further develop an AI-driven drug discovery platform, which is designed to identify therapeutic drugs for several different serious diseases.
(Xinhua) -- Agios leukemia drug Tibsovo Europe recently, Agios said it has withdrawn the acute leukemia drug Tibsovo in the European market for a sales license application, mainly for IDH1 mutation recurrence or recurring acute myeloid leukemia.
, the drug had been approved by the FDA for use in the allergy.
(Sina Pharmaceutical News) Ohitini new indications listing application by the FDA priority review today, AstraZeneone new indications listing application has been approved by the FDA priority review, PDUFA action date is the first quarter of 2021, the new indications for the treatment of early skin growth factor change non-small cell lung cancer patients after the removal of the root-treated tumor.
(Apex) Opdivo combination therapy was reviewed as a priority by the FDA today, with The Associated Press and Exelixis announcing that the FDA has accepted applications for additional biological product licensing and complementary new drugs for Opdivo and Cabometyx for patients with advanced renal cell carcinoma, respectively.
fda grants both applications priority review eligibility and is expected to respond by February 20, 2021.
gene editing therapy has been approved to launch a clinical trial of a potential cure therapy today, with Intellia Therapeutics, co-founded by one of the Nobel Laureates, announcing that the UK Medicines and Healthcare Products Regulatory Agency has authorized the company to launch Phase 1 clinical trials that will assess the effectiveness and safety of its gene editing therapy NTLA-2001 treatment of genetic trathyroxine protein amyloid combined with multiple neuropathy.
(Pharmaceutical Mingkangde) Hengrui Pharmaceutical Fluorine Pali Capsules and SHR3680 tablets of drug clinical trials approved by NMPA today, Hengrui Pharmaceuticals announced that recently received the Approval Notice of drug clinical trials issued by the State Drug Administration on fluorine pills and SHR3680 tablets, and will soon start clinical trials.
(Xinhua) -- Fosun Pharma: ORIN1001 tablets have been approved by the FDA for clinical trials of drugs today, Fosun Pharma announced that its controlling subsidiary Orinove Inc. has received a letter from the FDA agreeing to a clinical trial of ORIN1001 tablets for idiophedic pulmonary fibrosis treatment, which will soon be conducted in the United States for phase I clinical trials of the allergic disease.
(Sina Pharmaceutical News) Xinxusheng Technology Company Tau protein PET tracer in China was approved clinically today, CDE latest publicity, Xinxu pharmaceutical innovation product Tau protein PET tracer 18F-APN-1607 injection obtained a clinical trial implied license.
previously, the product had been approved by the FDA as an orphan drug.
(Pharmaceutical Mission) Garcos Pharmaceuticals SHP2 inhibitor was qualified as an FDA orphan drug today, Garcos Pharmaceuticals announced that the U.S. FDA has granted its original innovative drug JAB-3312 to treat esophageal cancer orphan drug qualification, which can be used to support the drug's global development in esophageal cancer adaptation.
this is a variant protein tyrosine phosphatase (SHP2) inhibitor, is its second self-designed and developed, small molecule with global intellectual property rights oral anti-tumor drugs.
(Pharmaceutical Mission) Chengdu Beit hepatitis B heavy drug fumarate propofol for Novowe tablets was approved on October 19, NMPA issued approval, Chengdu Pinter 4 generic drugs "Fumarate propofol tablets" was approved for listing, while the same through consistency evaluation, become the first imitation in China.
(Insight Database) Keystone Pharmaceuticals announced that PD-L1 antibodies have been approved for FDA orphan drugs on October 19, Keystone Pharmaceuticals announced that the U.S. FDA has granted its PD-L1 antibody Shuglida (CS1001) orphan drug eligibility for the treatment of T-cell lymphoma.
(Xinhua) -- First-line treatment or change of AIDS recently, the Lancet journal EClinical Mediaine published a major study supporting the use of dolutegravir as a first-line treatment for newly diagnosed HIV patients.
the study, commissioned by the WHO, is intended to provide insights into the update of the HIV antiretroviral treatment guidelines program.
(Medical New View point)