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Home » Newsletters » BioWorld

BioWorld

June 4, 2021

View Archived Issues
FDA-approved-stamp4.png

FDA approves Chimerix’s brincidofovir to treat smallpox

Following years of testing against a lengthy roster of viral foes, Chimerix Inc.'s Tembexa (brincidofovir) has finally won FDA approval as a medical countermeasure against smallpox. Read More

Liminal’s rare disease treatment, Ryplazim, is approved by FDA

A day before its June 5 PDUFA date and three months after its original PDUFA, Ryplazim (plasminogen, human-tvmh), from Liminal Biosciences Inc., won FDA approval for treating plasminogen deficiency type 1 hypoplasminogenemia, becoming the first approved therapy for the rare genetic disorder. Read More
Coins and charts

Record pace continues as 2021 financings rival last year

Although 2020 is the highest money-making year on record for the biopharma industry, a direct comparison of the first five months indicates that the amount raised so far in 2021 is 22% ahead of last year, while the number of financings climbed 26%. Read More
COVID-19 mRNA vaccine vials, syringe

Stemirna raises nearly $200M to advance mRNA COVID-19 vaccine

Stemirna Therapeutics Co. Ltd., which specializes in mRNA technology, said it raised nearly $200 million to speed up the clinical study of its COVID-19 vaccine candidate, SW-0123. It is in phase I study in China and preclinical data have been published in Nature. Read More
Pfizer-Biontech COVID-19 vaccine vial

Pfizer vaccine less effective against India variant of SARS-CoV-2

LONDON – A new U.K. study indicates the Pfizer Inc./Biontech SE COVID-19 vaccine is less effective against the India variant of the SARS-CoV-2 virus that was designated as of global concern by the World Health Organization (WHO) on May 10. Read More

ASCO 2021: Harpoon’s stock slides despite ‘great progress’ with HNP-424 at interim peek

Updated interim data from the ongoing dose-escalation portion of Harpoon Therapeutics Inc.’s phase I/IIa study of HPN-424 showed the metastatic castration-resistant prostate cancer therapy may move on to a dose expansion. Read More

ASCO 2021: Cullinan's Pearl: EGFR inhibitor shines in early stage NSCLC trial

Shares of Cullinan Oncology Inc. (NASDAQ:CGEM) rose 11.3% to close at $33.11 on June 4 as an update on its EGFR inhibitor, CLN-081, suggested it may prove competitive with Johnson & Johnson's recently approved treatment, Rybrevant (amivantamab), for adults with non-small-cell lung cancer (NSCLC) whose tumors bear EGFR exon 20 insertion mutations. Read More

ASCO 2021: Merus reports ‘important and clinically meaningful’ responses to zenocutuzumab in NRG1+ cancers

DUBLIN – The latest update from Merus NV’s phase I/II trial of zenocutuzumab (MCLA-128) – and its early access program – in patients with solid tumors harboring an NRG1-fusion offered a slight improvement on the data disclosed in an abstract released last month, in the run-up to the 2021 American Society of Clinical Oncology meeting. Read More

Sanofi eyeing adjuvant market as it advances oral SERD candidate in breast cancer

Sanofi SA is hoping an oral successor to Astrazeneca plc’s Faslodex (fulvestrant) could be a significant moneyspinner as it seeks to re-establish itself as a major player in oncology – and is pushing ahead with clinical trials to get it to market ahead of rivals. The Paris-based pharma has announced it is to start a new phase III trial of its second-generation oral selective estrogen receptor degrader (SERD) drug, amcenestrant, targeting high-risk patients with early breast cancer who need adjuvant drugs to suppress formation of secondary tumors after surgery. Read More

GI mojo strong as Redhill soldiers forth; PAMORA’s aura brightens

In February 2020, when Redhill Biopharma Ltd. acquired the peripherally acting mu-opioid receptor antagonist (PAMORA) Movantik (naloxegol) from Astrazeneca plc, new prescriptions were dropping. But that picture has turned around after about nine months of promotion, with strong reimbursement trends for the product, and Redhill may have positioned itself to become a leader in the gastrointestinal (GI) space. Read More

Appointments and advancements for June 4, 2021

New hires and promotions in the biopharma industry, including: Astrazeneca, Delix, Janux, Kura, Ovid. Read More

Conference data for June 4, 2021: ASCO

New and updated preclinical and clinical data presented by biopharma firms at the American Society of Clinical Oncology's annual meeting, including: Alligator, Amgen, Antengene, Beigene, Deciphera, Eli Lilly, Exelixis, Gilead, Magenta, Novartis, Phio, Puma, Spectrum, Tarveda, Yingli. Read More

Financings for June 4, 2021

Biopharmas raising money in public or private financings, including: Cyclerion, Imaginab, Monte Rosa, Ocuphire, Social Capital. Read More

In the clinic for June 4, 2021

Clinical updates, including trial initiations, enrollment status and data readouts and publications: 4D, Acadia, Advaccine, Albireo, Alzheon, Beyondspring, Galapagos, Gilead, Mirum, Point, Precision, Valbiotis, Valneva, Vincerx, Virios, Zynerba. Read More

Other news to note for June 4, 2021

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Akebia, Akoya, Auransa, Bioasis, BMS, Catalyst, Celgene, , Cyclerion, CNS, IGM, Innovent, Kye, Medunik, Pharvaris, Polarisqb, Roche, Surface. Read More

Regulatory actions for June 4, 2021

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ortho Regenerative Technologies, Pharmaessentia USA, Pharming Group, Regeneron, Visen. 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-June 3, 2021

Year-to-date money raised in public, private and other financings of biopharma companies. Read More
Hand holding IPO, financial icons

Biopharma money raised by month in 2021 (US$M)

Biopharma money raised to-date and by month in 2021, including public, private and other financings. Read More

BioWorld and Nasdaq stock indices

These graphs compare the performance of the biotech stocks for all of 2021 using the BioWorld Stock Indicator and the Nasdaq Biotech Index. Read More
stock prices up

Biggest gainers and losers for the week of June 1-4, 2021

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

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