Securities class action suits a growing fact of life for life sciences
Whether large or small, or based in the U.S. or abroad, life sciences companies are an increasingly attractive target for shareholder suits. The number of securities fraud class action suits filed in the U.S. in 2019 across all industries totaled 404, just one more than the 403 cases filed in 2018 and down from the peak of 412 in 2017, according to a new Dechert LLP report.

Securities class action suits a growing fact of life for life sciences
Whether large or small, or based in the U.S. or abroad, life sciences companies are an increasingly attractive target for shareholder suits. The number of securities fraud class action suits filed in the U.S. in 2019 across all industries totaled 404, just one more than the 403 cases filed in 2018 and down from the peak of 412 in 2017, according to a new Dechert LLP report.
Wuhan coronavirus is emergency in China, not yet international concern: WHO
LONDON – After a second day of deliberation, the World Health Organization (WHO) held off declaring that the novel coronavirus infection raging in Wuhan is an international health emergency, saying the low number of cases outside China means it is not time to escalate the response to this level.
Ionctura closes series A for next-generation dual-targeting cancer therapies
LONDON – Ionctura SA has closed a €15 million (US$16.6 million) series A to fund phase I development of its lead cancer program, IOA-244, and prepare a second product, IOA-289, for clinical development.
Soon-Shiong’s Nantkwest, Immunitybio still chasing cancer breakthroughs
Physician, scientist and investor Patrick Soon-Shiong might be considered a "square peg in a round hole," he admits. But the Abraxane (nab-paclitaxel) inventor's work to enlist natural killer, dendritic and T cells in what he calls a "triangle offense" against cancer is finally coalescing, he recently told BioWorld, with FDA registration filings for a combination immunotherapy approach in bladder, lung, Merkel cell and pancreatic cancer all within sight over the next several years.
Australia’s TGA proposes fee increases to implement recent drug, device reforms
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is seeking input from industry stakeholders on a proposal to increase its fees to cover projected deficits this year. The proposal outlines three options.
Ireland’s embrace of genomics remains tentative
DUBLIN – “Welcome to the conversation,” Abbvie Inc.’s head of genomic research, Howard Jacob, an early pioneer of genomics-driven medicine, told delegates during a keynote address at the Genomics Summit 2020 event Jan. 23. Ireland is very much a latecomer to that conversation and it has yet, as a country, to figure out what the shape of its contribution to the genomic era of medicine is going to be.

Analysis and data insight

Biopharmaceutical collaborations: December 2019
Biopharma licensings, joint ventures and collaborations, including: Abbvie, Amyris, Athenex, Biocon, Bridgebio, Codexis, Eisai, Eli Lilly, Fulcrum, Genentech, Gilead, Hitgen, Janssen, Kodiak, Ligand, Merck, Mochida, Nicox, Onconova, Pulmatrix, Retrogenix, Sarepta, Sunesis, Tracon, Ultragenyx,...
Completed biopharmaceutical mergers & acquisitions: December 2019
Completed biopharma M&As, including: Astellas, Cambrex, Castle Creek, Dendrimer, Effepharm, Fibrocell, Gemphire, Immunovant, J&J, Kyowa, Neurobo, Permira, Roche, Spark, Taris, Xyphos
Collaborations between biopharmaceutical companies and government/nonprofit entities: December 2019
Deals between biopharma companies and government or nonprofit entities, including: Abbvie, Advaite, Aptahem, Baergic Bio, Bayer, Bellicum, Bloom Science, EMD Serono, Enochian, Evgen, Hoth, Indivior, Kazia, Regeneron, Sanofi Pasteur, Syntekabio, Theragnostics, Vaccitech
Biopharma money raised: Jan. 1-23, 2020
Year-to-date money raised in public, private and other financings of biopharma companies.

Financings

Born again: Neurotrope back in the game with bryostatin-1 in Alzheimer’s
Clinical
It was a trifecta to remember for Neurotrope Inc. on Wednesday as the company cast revealing light on a seemingly failed clinical program involving its lead candidate, had the NIH offer a grant to create a phase II trial to explore the program’s strengths, and then found institutional investors and individuals to pony up an $18 million registered direct offering for the company’s securities. It was a re-examination of data that resurrected Neurotrope’s hopes for its lead candidate months after a confirmatory phase II of bryostatin-1 failed to outperform a placebo in people with moderately severe to severe Alzheimer’s disease (AD) in the absence of Namenda (memantine, Allergan plc), an NMDA receptor antagonist.

Science

Oncogene Ras affects memory consolidation
Neurology/Psychiatric
Remember how Ras is a frequently mutated oncogene in solid tumors? Well, it turns out Ras plays a role in those memories, too. In the Jan. 13, 2020, online issue of the Proceedings of the National Academy of Sciences, scientists at the Scripps Research Institute in Juniper, Fla., reported on the...

Bench Press for Jan. 17, 2020
Scientists at the Whitehead Institute have discovered that the ability of the parasite Toxoplasma gondii to cause chronic infections depends on changes orchestrated by a single transcription factor, Bradyzoite-formation deficient 1 (BFD1).
Lung cancer treatment options much improved, but resistance remains
Cancer
It is equally fair to say that lung cancer treatment has come a long way, and that it has a long way to go. Speaking at a joint conference by the International Association for the Study of Lung Cancer and the American Association for Cancer Research on lung cancer translational research, William...

Newco news

Kintai’s good PEMmanship draws gutsy map to obesity and more
Obesity
Kintai Therapeutics Inc. CEO, president and board member Paul-Peter Tak told BioWorld that the company aims to reach the clinic in the first quarter of next year with obesity agent KTX-0200, which has begun IND-enabling studies after showing sustained weight loss and improved markers of health in preclinical experiments.
Arpeggio Bio nabs $3.2M to advance nascent RNA drug screen
RNA
Boulder, Colo.-based startup Arpeggio Biosciences Inc. scooped up $3.2 million in seed funding in a round led by Khosla Ventures, with participation by Fundersclub, Fifty Years, TechU and Y Combinator.
Kyverna Therapeutics emerges with $25M series A and a $587M Gilead agreement
Inflammatory
Not only did newly emergent Kyverna Therapeutics Inc. burst out of the gate with a $25 million series A, but it enhanced its entrance with a deal from Gilead Sciences Inc., one of the company’s initial funders, potentially worth $587.5 million.
AI startup Zebiai inks new deals with Google and X-Chem
Artificial intelligence
When Zebiai Therapeutics Inc.’s CEO, Rick Wagner, went about naming his new machine learning company, he wanted it to connote something dramatic that displayed the company’s potential to reach into the seemingly boundless future technology had unlocked.
Genesen secures $1.9M for peptide-based autoimmune disease treatment
Immune
HONG KONG – South Korean biopharma Genesen Inc. has secured ₩2.2 billion (US$1.9 million) in seed funding to advance its peptide-based drug candidates for the treatment of autoimmune and inflammatory diseases, including systemic lupus erythematosus (SLE), rheumatoid arthritis and psoriasis.

U.S.

Cancer genomic tests often aren’t done to guideline; germline data presents unique issues
Conferences
SANTA CLARA, Calif. – Just as it does with treatments, the National Comprehensive Cancer Network (NCCN) offers detailed guidelines on genomic testing by cancer type. These are key in determining what physicians can prescribe routinely and what insurers will cover. But those guidelines aren’t followed regularly outside a major research hospital setting, thereby obviating access to tumor genetic information that could help to better guide treatment. Even if current guidelines are followed, physicians and patients can get information back from the tests that neither party is prepared to process.

Europe

U.K. group issues CID trial recommendations to accelerate access to innovative drugs
Clinical
LONDON – A high level U.K. group, involving industry, academia, patients, health technology assessment and regulatory representatives, has set out guidelines for designing complex cancer trials and is calling for their rapid implementation to reduce clinical development timelines.

European biotech edges to new investment high of $7.7B in 2019
Financings
DUBLIN – Last year was yet another banner year for European biotechnology firms engaged in drug development. The sector took in $7.739 billion in equity funding in 2019, just edging past the previous high of $7.715 billion it reached in 2018. The second half of the year was a marked improvement on...
Year in Review: Drawn-out Brexit takes toll as industry hopes for stability in 2020
LONDON – Following 3.5 years of uncertainty, the U.K. will be leaving the EU at 11 pm on Jan. 31, after the newly elected Conservative government finally got the withdrawal agreement bill voted through parliament on Dec. 20, by a majority of 124.

Clinical

Tennor’s prosthetic joint infections therapy, TNP-2092, set to start phase III soon
Infection
BEIJING – With promising phase II data in hand – and newly designated FDA orphan drug status – Suzhou, China-based Tennor Therapeutics Suzhou Co. Ltd. is gearing up to move into pivotal testing with TNP-2092 to treat prosthetic joint infections.
Chi-Med’s surufatinib phase III trial halted early after meeting primary endpoint in advanced pancreatic NET
Cancer
BEIJING – Hong Kong-headquartered Hutchison China Meditech Ltd.’s (Chi-Med) called an early stop to its phase III pivotal study of surufatinib in advanced pancreatic neuroendocrine tumors (NET) in China after it met the predefined primary endpoint of progression-free survival.
Clene Nanomedicine’s phase II for ALS muscles ahead
Neurology/Psychiatric
What’s new inevitably includes an element of the old. Clene Nanomedicine Inc., which just completed enrollment and dosed the first patient in its phase II trial in amyotrophic lateral sclerosis (ALS), literally contains an element of the old in its lead nanocatalytic therapy: gold.
Adaptimmune SPEARs 4 partial responses in various tumor types
Cancer
While companies have seen plenty of success treating blood cancers with T-cell therapies, solid tumors have largely remained the holy grail for T cells. But Adaptimmune Therapeutics plc has early data from its Specific Peptide Enhanced Affinity Receptor T-cell platform suggesting it may be on the right path for a platform with a wide breadth.
Mine, oil mine? Amarin CV fish rivals sink as generic-makers angle for catches in IP
Cardiovascular
With a label broadened by the FDA in December and two aspiring competitors apparently picked off via late-stage trial blowups, Amarin Corp. plc finds itself in strong position with fish oil therapy Vascepa (icosapent ethyl) – at least pending the outcome of court proceedings that involve challengers to patents for the cardiovascular (CV) drug.
Verona climbs on solid phase IIb data for COPD therapy; phase III to start this year
Respiratory
LONDON – Verona Pharma plc reported positive phase IIb results for the nebulized formulation of its dual phosphodiesterase (PDE) 3 and 4 inhibitor, ensifentrine (RPL-554), as an add-on to standard bronchodilation therapy in chronic obstructive pulmonary disorder (COPD).

BioWorld Perspectives

A decade of incentives to promote antibiotic development and still no viable route to commercial success
It should be motoring to profitability, but nine months after the U.S. launch of its new antibiotic, Zemdri (plazomicin), Achaogen Inc. has filed for...
BioWorld's Top 10: Biggest newsmakers and trending stories of 2018
BioWorld
In many ways, 2018 resembled the previous year in fast motion. Political turmoil accelerated on both sides of the Atlantic, with Asia swept into the fold,...
Deck the halls, or get decked out: BioWorld’s 12th annual Holiday Gift Guide
BioWorld
The holidays are (already) here again. Much as we try to push back the calendar, those Thanksgiving doorbuster, Black Friday blowout, Small Business...
Price increases - tone deaf or defiant?
BioWorld
Defying the laws of nature, many drug companies seem intent on proving that what goes up doesn’t have to come down. For them, the sky’s the limit when it...
PABNAB – A disappointing distraction at BIO, not associated with BIO
BioWorld
On what planet are the PABNAB (Party at BIO not associated with BIO) organizers living to think it was acceptable to spotlight topless dancers with company...
Shoes, ‘Stones’ and surfing: BioWorld’s 12th annual Summer Reading List
BioWorld
Summer arrives with a bang for biopharma in the dueling agendas of the American Society of Clinical Oncology (ASCO) annual meeting, the BIO International...
If no one reads it, what’s the purpose of a drug label?
BioWorld
Robert Califf said it when he was serving as FDA commissioner. Patient advocates have said it when testifying before Congress or commenting at public...

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