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Home » Newsletters » BioWorld

BioWorld

March 27, 2020

View Archived Issues
regulatory-thumbs-up

Triferic’s I.V. formulation gets FDA approval, alongside previously approved Triferic Dialysate

Now that Rockwell Medical Inc.’s intravenous formulation of Triferic, Triferic AVNU (ferric pyrophosphate citrate) is FDA-approved, the nod coming a day before its PDUFA date of March 28, the company plans putting evaluation programs into action during the third quarter of this year. Only after those programs’ completion will the formulation be available commercially. Read More

Intelgenx garners CRL for migraine candidate Rizaport Versafilm

Not long after a morning earnings call on March 27 in which Intelgenx Corp. CEO Horst Zerbe said his team was still awaiting word from the FDA on its resubmitted 505(b)(2) application for its acute migraine candidate, Rizaport Versafilm, that news arrived in the form of a complete response letter (CRL), its third following earlier CRLs in February 2014 and April 2019. Read More
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CHMP nods through multiple applications during virtual March meeting

DUBLIN – Novartis AG, Bristol Myers Squibb Co. and Sanofi SA were among firms that secured positive opinions from EMA’s Committee for Medicinal Products for Human Use (CHMP) on marketing authorization applications for new therapies, which will progress to formal approvals 67 days from now. Because of the COVID-19 pandemic, the committee’s March meeting was held virtually. Read More
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China’s Abbisko rakes in $70M series C funding amid economic turbulence

HONG KONG – Chinese biopharmaceutical company Abbisko Therapeutics Co. Ltd., of Shanghai, defied turbulent stock markets amid the COVID-19 pandemic to snag $70 million in its latest round of financing. Read More
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Closing panel offers COVID-19 lessons to learn from China

Biopharma industry leaders in China who were the first to experience the chaos of the COVID-19 pandemic shared their thoughts during a closing plenary session of the virtual Bio-Europe Spring 2020 meeting. Read More
Virtual meetings

Conferences go virtual, postpone, as COVID-19 spreads and Bio-Europe Spring wraps up

The five-day Bio-Europe Spring 2020 conference, possibly the first ever life sciences partnering event staged in an all-virtual format, ended on Friday, March 27, with high hopes that the industry would return to face-to-face interactions next year in Barcelona. Read More
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South Korea’s Qurient posts phase II success with telacebec in drug-resistant TB

HONG KONG – Phase II data of South Korea-based Qurient Co. Ltd.’s novel antibiotic candidate may offer hope that the first universal regimen to treat tuberculosis (TB) regardless of drug resistance status has been found. Read More
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FDA authorizes Pear Therapeutics' prescription digital insomnia therapy

Pear Therapeutics Inc. obtained FDA approval for Somryst, the first prescription digital therapeutic for chronic insomnia. The app provides structured cognitive behavior therapy (CBT) with clinical dashboards for physicians. While CBT is the recommended first-line therapy for insomnia, the U.S. has only 500 therapists certified to provide CBT for insomnia (CBTi) for the estimated 30 million Americans who suffer from chronic difficulty going to and staying asleep. Read More
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Bench Press for March 27, 2020

BioWorld looks at translational medicine, including: How the eye cleans itself up; In blood stem cells, selection drives driver mutations early on; Dead cells do tell tales; Selective TGF-beta inhibition helps checkpoint blockade; How lung tumors seed to brain; Butyrate affects regulatory B cells, rheumatoid arthritis; Lamin A/C’s presence in nucleus, absence from membrane both problematic in progeria; Females, males have different metabolic response to intermittent fasting; Ditching PAMs expands CRISPR. Read More

Appointments and advancements for March 27, 2020

New hires and promotions in the biopharma industry, including: Allied, Cognition, Genmab, I-Mab, Immune, Mereo, Xortx. Read More

Financings for March 27, 2020

Biopharmas raising money in public or private financings, including: Hemostemix, Karolinska, Novan, Zealand. Read More

In the clinic for March 27, 2020

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Altasciences, Arbutus, Translate Bio. Read More

Other news to note for March 27, 2020

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alphamab Oncology, Azargen, Bold, CG Oncology, Cytodyn, Dicerna, Diurnal, Enanta, Epivax, Equillium, Eton, Ibio, Incelldx, Innoplexus, Kissei, Pfizer, Revance, Rising Pharma, Sanofi Pasteur, Vaxil, Vertex, Vyripharm. Read More

Regulatory actions for March 27, 2020

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avexis, BMS, Cstone, Cytodyn, Eisai, Genentech, Humanigen, Intelgenx, Lupin, Mylan, Novartis, Pharming, Rockwell, Sanofi, Translate Bio. Read More

Biopharma money raised: Jan. 1-March 26, 2020

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

Money raised by biopharma: 2020 vs. 2019

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

Biggest gainers and losers for the week of March 23-27, 2020

The top 10 biopharma stock gainers and losers for the week. Read More
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Completed biopharmaceutical mergers & acquisitions: February 2020

Completed biopharma M&As, including: Aevi Genomic Medicine, Anika, Arthrosurface, Attenua, Aytu, Cerecor, Coda, Dermira, Eli Lilly, Innovus, Promedior, Pvp, Roche, Takeda. Read More

Biopharmaceutical collaborations: February 2020

Biopharma licensings, joint ventures and collaborations, including: Achaogen, Advaxis, Aimmune, Aptevo, Aradigm, Astrazeneca, Atreca, Bicycle, Biogen, Caribou, Catalent, Cellectis, Cipla, Clover, Collegium, Curis, Cytodyn, Daewoong, Dyadic, Eisai, Evotec, Eyepoint, Genentech, Glenmark, Grifols, GSK, Hanmi, Hikma, Hollister, Hummingbird, Icagen, Immunos, Innocare, Janssen, Jounce, Karuna, Karyopharm, Kissei, Ligand, Luye, Medivir, Merck, Mylan, Nanostring, Norgine, Noxopharm, Otologic, Paratek, Pfizer, Portola, Probiogen, Redhill, Roche, Sangamo, Sarepta, Tetra, Trianni, Wize, Wockhardt, Wuxi, Xencor, Zeria, Zy. Read More

Collaborations between biopharmaceutical companies and government/nonprofit entities: February 2020

Deals between biopharma companies and government or nonprofit entities, including: AB Biotics, ACT Genomics, Active Biotech, Active Motif, Agex, Be Cool, Benevolentai, Berg Pharma, Berkeley Lights, Beroni, Biomarin, Bridge, Cellular Biomedicine, Chugai, Cocrystal, Dianomi, Dyadic, Enochian, Entourage Phytolab, Erytech, Evgen, Exicure, FDA, Gemini, Generex, Genprex, Gibson Oncology, Gilead Sciences, GSK, Innovation, J&J, Medigen, NIH, Novartis, Oncologie, Orgenesis, Sanofi Pasteur, Sapphire, Synspira, Theratechnologies, Toa Eiyo, Tonix, VBL, Venturis, WPD. Read More

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