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Home » Newsletters » BioWorld

BioWorld

July 16, 2021

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IPO stock market ticker

IPOs continue their record surge with three debuts

Three companies that began trading on Nasdaq on July 16 are contributing to this year’s record-setting pace of biotech IPOs. Erasca Inc., which is looking to raise $300 million, led the pack with shares (NASDAQ:ERAS) ending the day at $17.43, an 8.94% rise from the opening asking price of $16. Read More

ICER panel: Aduhelm cost not glossed as Biogen balks about talks

A sometimes contentious policy roundtable on how to handle Alzheimer’s disease therapies followed the July 15 meeting of the California Technology Assessment Forum, an independent evidence appraisal committee of the Institute for Clinical and Economic Review (ICER). CTAF’s 15 panelists voted unanimously that the evidence was not adequate to prove Biogen Inc.’s recently approved Aduhelm (aducanumab) superior to supportive care alone. Read More
Chinese flag and microscopes

China now wants quality, not just quantity

China’s Center for Drug Evaluation has released the guideline on developing oncology drugs with a clinical value-oriented approach, part of its ongoing efforts to encourage the development of truly innovative oncology drugs in China. Read More
Acute myeloid leukemia

Suda Pharmaceuticals to combine new iNKT cell therapy platform with CARs to target blood cancers

PERTH, Australia – Suda Pharmaceuticals Ltd. saw its stock shoot up nearly 44% on the heels of an oversubscribed AU$3.65 million (US$2.71 million) capital raise after acquiring a new invariant natural killer T (iNKT) cell therapy platform for oncology. Read More
Nurse holds Ipad with elderly patients

Orexo initiates study combining digital therapy and medication for opioid use disorder

Orexo AB enrolled the first patient in a pivotal trial of its digital therapeutic Modia plus sublingual buprenorphine/naloxone for treatment of opioid use disorder (OUD). Orexo’s Zubsolv, the combination of buprenorphine and naloxone used in the study, has been employed to help U.S. patients with OUD since 2013. Read More
FDA-yellow-dice.png

FDA pressing for greater budget authority for Office of Regulatory Affairs

The COVID-19 pandemic brought in-person inspections of device manufacturing sites to a near halt, but that has left the agency with a significant backlog in these inspections. The FDA’s Associate Commissioner for Regulatory Affairs Judith McMeekin said recently that the FDA is intent on prodding Congress to provide the Office of Regulatory Affairs (ORA) with more monies, particularly given the meager increases in funding for oversight of the med-tech industry in the past few years. Read More

Biocytogen forms partnership and closes new financing round

Having created a profitable preclinical services business, Biocytogen Pharmaceuticals Co. Ltd. is now working to develop its own pipeline of antibody therapeutics, recently inking a partnership with China Resources Biopharmaceutical Co. Ltd to develop drugs for oncology and immunology indications and raising “tens of millions of dollars” in a new financing round to support the development of its antibody drugs. Read More

Clinical activity slows, COVID-19 work falls, but 2021 still ahead of last year

While overall clinical trial activity appears to be slowing, June was the busiest month for the year, and, in fact, all of last year, with a total of 436 items of news related to phase I, phase II and phase III research. Read More

Appointments and advancements for July 16, 2021

New hires and promotions in the biopharma industry, including: Asceneuron, Certara, Eurekare, Viridian. Read More

Financings for July 16, 2021

Biopharmas raising money in public or private financings, including: Candel, Celularity, Cytrx, Dynacure, Modulus, Modus, Regencell. Read More

In the clinic for July 16, 2021

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Advaxis, Aeglea, Bio-Thera, Compugen, Galapagos, Incyte, Mirror, Synlogic, Transcenta, Vir. Read More

Other news to note for July 16, 2021

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Checkmate, Constellation, Exevir, Generate, Gentibio, Forge, Halucenex, J&J, Kuros, Lexaria, Mithra, Morphosys, Pharmenable, Puma, Red Light Holland, Rubius, Sana, Xoma. Read More

Regulatory actions for July 16, 2021

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biomarin, Canbridge, Direct, Emmaus, Navidea, NLS, Ocugen, RDIF, Theratechnologies. Read More

Money raised by biopharma: 2021 vs. 2020 vs. 2019

Total raised in public, private and other financings of biopharma companies, comparing 2021 vs. 2020 vs. 2019. Read More

Biopharma money raised: Jan. 1-July 15, 2021

Year-to-date money raised in public, private and other financings of biopharma companies. Read More
stock prices up

Biggest gainers and losers for the week of July 12-16, 2021

The top 10 biopharma stock gainers and losers for the week. Read More

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