1.Pfizer and Amgen Release Annual Reports in Succession
Pfizer Announces 2019 Annual Results: Revenue of $51.8 Billion, a 2% Year-on-Year Increase
Pfizer recently announced its 2019 annual results. The company’s total revenue for 2019 amounted to $51.8 billion, representing a 2% increase when excluding the impact of the Upjohn business. The Biopharmaceuticals segment generated total revenues of $39.4 billion in 2019, an 8% growth driven primarily by Ibrance, Eliquis, Xeljanz, and Vyndaqel, as well as a 14% revenue increase in emerging markets. Upjohn’s total revenue for 2019 was $10.2 billion, with its China revenue growing by 7% for the year.
As of January 28, 2020, Pfizer had 95 R&D projects underway, including 58 new molecular entities, 34 new indications, and 3 biosimilars.
Currently, 23 R&D projects are in Phase III clinical trials, covering oncology, inflammation and immunology, internal medicine, vaccines, and rare diseases.
9The R&D project is undergoing the registration process.
Chairman and Chief Executive Officer Albert Bourla stated:2019 was a busy year for Pfizer, highlighted by: robust financial performance, shareholder-friendly capital allocation, our increasingly robust R&D pipeline, and the formation of a joint venture between Pfizer Consumer Healthcare (PCH) and GlaxoSmithKline (GSK). The final agreement to merge Upjohn and Mylan was also announced, creating a new global pharmaceutical company—Viatris—marking a significant milestone in Pfizer’s journey toward becoming a more focused global leader in innovative medicines.
Amgen Announces 2019 Financial Results: Revenue of $23.362 Billion, Down 2% Year Over Year
On January 30, Amgen announced its 2019 financial results, reporting total annual revenue of $23.362 billion, a 2% year-over-year decline, primarily driven by sharp decreases in sales of several core legacy products, including Neulasta, Sensipar/Mimpara, Epogen, and Neupogen.
2.Over the past 24 hours, VCBeat has monitored one investment and financing event in the biopharmaceutical sector.。
Biopharmaceutical Company Arcutis Lists on Nasdaq, Raising Nearly $160 Million in IPO
Recently, Arcutis Biotherapeutics, a biopharmaceutical company based in California, USA, announced its official listing on the Nasdaq. The company raised nearly $160 million through its initial public offering (IPO), which will be used to advance the development of multiple dermatological therapeutics.
3.Under review: one case in Canada and two cases with the FDA.
Health Canada Approves Merck and Pfizer’s Combination Therapy Keytruda + Inlyta
Recently, Merck announced that Health Canada has approved the anti-PD-1 therapy Keytruda (pembrolizumab) in combination with Pfizer’s tyrosine kinase inhibitor Inlyta (axitinib) for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
Lilly’s RET Inhibitor Selpercatinib Granted FDA Priority Review, with Approval Expected in Q3
Recently, Eli Lilly and Company announced that its RET inhibitor selpercatinib (LOXO-292) has been granted Priority Review by the U.S. FDA, potentially accelerating approval for the treatment of patients with advanced RET fusion-positive non-small cell lung cancer (NSCLC), RET-mutant medullary thyroid cancer (MTC), and RET fusion-positive thyroid cancer. The FDA is expected to respond to the New Drug Application (NDA) in the third quarter of this year.
Aprea’s Combination Therapy for Blood Cancer Receives FDA Breakthrough Therapy Designation
Recently, pharmaceutical company Aprea Therapeutics announced that the FDA has granted Breakthrough Therapy Designation to its investigational therapy APR-246, in combination with azacitidine, for the treatment of patients with myelodysplastic syndromes (MDS) harboring TP53 mutations.
Bayer’s Nubeqa Significantly Prolongs Overall Survival in Pivotal Phase III Trial
Recently, Bayer announced the final analysis results of the pre-specified overall survival (OS) endpoint from the pivotal Phase III ARAMIS study evaluating Nubeqa (darolutamide) for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC). The data demonstrated that Nubeqa plus androgen deprivation therapy (ADT) resulted in a statistically significant improvement in OS compared with placebo plus ADT.
Autolus Reports Positive Data from Phase 1/2 Clinical Trial of Investigational Lymphoma Drug
Recently, Autolus Therapeutics announced positive data from its Phase 1/2 ALEXANDER clinical trial evaluating AUTO3, an investigational therapy, in adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Data as of January 21, 2020, showed that in the patient subgroup receiving AUTO3 at a dose of 450 × 10⁶ cells in combination with pembrolizumab, the overall response rate (ORR) was 71%, with a complete response rate (CRR) of 57%.
Junshi Biosciences' Recombinant Humanized Anti-BTLA Monoclonal Antibody Approved for Clinical Trials
On February 3, the Center for Drug Evaluation (CDE) updated data in its clinical trial approval section, announcing that Junshi Biosciences’ Class 1 novel drug, “Recombinant Humanized Anti-BTLA Monoclonal Antibody Injection,” had received clinical trial approval for the treatment of unresectable or metastatic advanced solid tumors (including lymphoma).
Takeda Submits Marketing Application for Cabometyx in Japan for the Treatment of Liver Cancer
Recently, Exelixis announced that its partner Takeda has submitted a marketing application in Japan for Cabometyx (cabozantinib) to treat unresectable hepatocellular carcinoma that has progressed following prior therapy. Cabometyx is an oral small-molecule tyrosine kinase inhibitor developed by Exelixis that inhibits the activity of c-Met, VEGFR2, as well as AXL and RET kinases. It has already been approved in the United States for the treatment of advanced renal cell carcinoma (RCC).
Bristol Myers Squibb Withdraws Marketing Application for Opdivo-Yervoy Combination as First-Line Treatment for Lung Cancer
Recently, Bristol Myers Squibb (BMS) announced that it has withdrawn its application for the use of Opdivo in combination with Yervoy as a first-line treatment for advanced non-small cell lung cancer (NSCLC) in the European Union. The application, initially submitted in 2018, was based on data from the Phase 3 CheckMate-227 clinical trial. Although the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency acknowledged the integrity of the trial data, the CHMP ultimately concluded that it was “unable to conduct a comprehensive assessment of the application” and rejected it.
Chinese Scientists Discover Scientific Evidence of Fecal-Oral Transmission of the Novel Coronavirus
A recent study published on the preprint server bioRxiv suggests that the gastrointestinal tract may also serve as a transmission route for the novel coronavirus. Conducted jointly by scientists from Naval Medical University, Tsinghua University, and Tongji University, the study employed single-cell sequencing technology, analyzing nearly 230,000 cells. The findings indicate that the proportion of ACE2-expressing cells in the colon and ileum is higher than the pulmonary data reported in previous studies.
U.S. Department of Health Approves Novartis to Cover Travel Expenses for Low-Income Patients Undergoing CAR-T TherapyUse
Recently, the U.S. Department of Health and Human Services (HHS) established a specific waiver rule for Novartis’ innovative therapy, Kymriah. Under this HHS rule, Novartis is permitted to cover all out-of-pocket expenses—including transportation, accommodation, meals, and other costs—for low-income patients enrolled in Medicare and Medicaid, provided they meet specified criteria, while these patients are hospitalized to receive Kymriah treatment and undergo subsequent clinical monitoring.
Chunyu Doctor Partners with Over 30 Institutions to Launch Online Free Clinics for COVID-19
Recently, Chunyu Doctor, in collaboration with Health News, People’s Good Doctor, and over 30 other institutions, jointly launched a free online charity consultation campaign. Since January 25, the special online consultation initiative titled “Jointly Fighting the Coronavirus” has been officially launched on channels including the Chunyu Doctor APP, mini-programs, and its open platform. Users can access these services through Chunyu Doctor’s official platforms and partner channels to consult on issues related to respiratory diseases and novel coronavirus pneumonia. This charity consultation campaign focuses on addressing user inquiries concerning respiratory medicine, infectious diseases, and other relevant departments related to novel coronavirus infection, while giving priority support to users in Hubei Province, where the number of infections is concentrated.