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BioWorld - Wednesday, May 18, 2022
Breaking News: Try BioWorld for free for two weeksBreaking News: Evotec, Sernova team up to develop functional cure for type 1 diabetesBreaking News: Try BioWorld for free for two weeks
  • China U.S. deal

    Merck acquires global rights to cancer drug from Kelun in $1.4B deal

    In a deal potentially worth more than $1.4 billion, Sichuan Kelun Pharmaceutical Co. Ltd. has out-licensed a large molecule drug in cancer to Merck & Co. Inc. for development and commercialization outside mainland China, Hong Kong, Macao, and Taiwan.
  • UK biotech RQ Bio emerges with $157M COVID-19 antibody deal with Astrazeneca

  • Evotec, Sernova team up to develop functional cure for type 1 diabetes

  • F2G finds partner for antifungal olorofim in $480M Shionogi deal

  • Avrobio’s gene therapy prompts positive phase I/II data in cystinosis

  • Today's news in brief

  • Merck acquires global rights to cancer drug from Kelun in $1.4B deal

    In a deal potentially worth more than $1.4 billion, Sichuan Kelun Pharmaceutical Co. Ltd. has out-licensed a large molecule drug in cancer to Merck & Co. Inc. for development and commercialization outside mainland China, Hong Kong, Macao, and Taiwan.
  • UK biotech RQ Bio emerges with $157M COVID-19 antibody deal with Astrazeneca

    An unknown U.K. biotech, RQ Biotechnology Ltd., has emerged from stealth mode with a $157 million licensing deal with Astrazeneca plc for its monoclonal antibodies, aimed at protecting vulnerable and immunosuppressed people against SARS-CoV-2.
  • Evotec, Sernova team up to develop functional cure for type 1 diabetes

    Evotec AG and Sernova Corp. are joining forces in a bid to develop a functional cure for type 1 diabetes. The companies plan to file an IND early in 2024 for a combined cell therapy and medical device product comprising Evotec’s human beta cells, derived from the company’s induced pluripotent stem cell platform, and Sernova’s Cell Pouch delivery system, which provides transplanted cells with a vascularized, physiologically appropriate environment that enables them to secrete insulin and other hormones involved in regulating blood glucose levels.
  • F2G finds partner for antifungal olorofim in $480M Shionogi deal

    Antifungals specialist F2G Ltd. has signed an agreement with Japanese pharma Shionogi & Co. Ltd. for development and commercialization of its treatment for invasive aspergillosis in both Asia and Europe. Under the terms of the deal, F2G is getting $100 million up front and regulatory and commercialization milestones of up to $380 million. The two partners will share clinical development costs.
  • Avrobio’s gene therapy prompts positive phase I/II data in cystinosis

    It was a patient-reported outcome, one that could actually be seen in the mirror, that alerted researchers they might be on track in their phase I/II study of cystinosis. The patient noticed that for the first time in his life his hair had become darker, like his brother’s. It was all because the rare disease inhibiting the pigment in his body was being impacted by the treatment. “It’s a secondary issue, but I find it fascinating,” Avrobio Inc.’s CEO, Geoff Mackay, told BioWorld. “When you run trials like this, you stumble upon some fascinating results.”
  • Today's news in brief

    BioWorld briefs for May 17, 2022.
  • US FDA lowers age for COVID-19 boosters to 5 years old

    While children younger than 5 in the U.S. still have no vaccine protection against COVID-19, those 5 and older may be able to get a third jab. The FDA authorized, May 17, the use of a single booster dose of the Pfizer Inc.-Biontech SE vaccine for kids 5 through 11 years of age who completed the primary two-dose series at least five months earlier.
  • Nouscom unveils Janssen deal as lead cancer vaccine cleared for trials

    Off-the-shelf cancer vaccine specialist Nouscom AG has taken the wraps off a multiproject agreement with Janssen Research and Development LLC, after the lead candidate received FDA approval to enter clinical trials.
  • Pfizer breathes life into biopharma M&As; Jazz leads dealmaking

    While biopharma mergers and acquisitions are at an all-time low, a company that stood in the front battle lines fighting the COVID-19 pandemic not only completed the top M&A so far in 2022, but it also announced plans for another mega-merger shortly thereafter.
  • US FDA updates drug OOS guidance

    Rather than drafting a new guidance, the U.S. FDA’s Center for Drug Evaluation and Research made some clarifying revisions to update its 16-year-old final guidance, “Investigating out-of-specification (OOS) test results for pharmaceutical production.”

BioWorld Insider Podcast

Biopharma’s correction? 2022 1Q investments are both up and down. BioWorld Senior Analyst Karen Carey explores the data with staff writer Lee Landenberger, explaining what happened in Q1 and where Q2 is headed.

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Analysis and data insight

  • Stock chart with falling red arrow

    Biopharma stock downturn creates buying opportunity for investors

    Signs of hope at the end of March were quickly dashed in the last several weeks as BioWorld’s Biopharmaceutical Index (BBI) plunged once again, albeit not as dramatically as the Nasdaq Biotechnology Index. The BBI is down by 4.4% for the year, as of May 11, while NBI has fallen 28.5%. The Dow Jones...
  • Globe and currency symbols

    At $18B so far, 2022 biopharma financings lag 2021 pace

    Financings
    With 47% fewer biopharma financings than last year, investors who were once enthused over the industry’s potential in combatting the deadly SARS-CoV-2 virus appear to be taking a step back. So far in 2022, the industry has raised $18 billion across 346 financings through the first week of May. By...
  • FDA approved metal stamp

    US approvals drop as FDA moves toward modernization

    Regulatory
    As the U.S. FDA transitions to another new commissioner, the number of approvals has dropped to the lowest levels in seven years and is 19% below those approved by this time last year.
  • Global vaccine illustration

    As COVID numbers drop, biopharma research remains steadfast

    Coronavirus
    For the first time since the early weeks of the COVID-19 pandemic in 2020, global deaths caused by the disease have fallen to their lowest point, as immunity against the SARS-CoV-2 virus and its variants continues to build. Infections and deaths appear to be decelerating, an optimistic sign that...
More in Analysis and data insight

Today's news in brief

  • Appointments and advancements for May 17, 2022

  • Financings for May 17, 2022

  • In the clinic for May 17, 2022

  • Other news to note for May 17, 2022

  • Regulatory actions for May 17, 2022

Deals and M&A

  • Astrazeneca widens hunt for epigenetic drugs in second Proteros deal

  • Europe scraps order for 60M doses of Valneva COVID vaccine

  • Chimerix stock falls despite balance sheet boost via $225M Tembexa sale

  • Zhaoke licenses Asian rights to Visus presbyopia candidates in $130M deal

  • Orion picks up rights to Jemincare non-opioid pain drug in €15M deal

  • Taiho goes Pearl diving, brings up $405M Cullinan deal

  • Bridgebio bolsters itself with a $1.8B BMS deal

  • Mooted reverse merger with Medsenic a lifeline for Bone Therapeutics

  • Zhifei Lvzhu wins rights to whooping cough vaccine from Intravacc

  • CGRPs on the ascent in migraine, Pfizer paying $11.6B for Biohaven

Financings

  • 3D Euro symbol

    Biotech, pharma ‘dance’ ongoing as Apollo commits as much as €1B to Sofinnova

    Europe
    Apollo Global Management Inc. is taking a minority equity interest in European venture capital firm Sofinnova Partners, pledging to commit of up to €1 billion (US$1.04 billion) in managed capital to the latter’s investment coffers.
  • Kriya lands $270M series C as it hones gene therapy pipeline

    Cancer
  • LSX World Congress: Despite the discord of 2022, the music is not over in biotech investment

    IPO
  • Moma’s moment comes with a $150M series B to target solid tumors

    Cancer
  • Askgene’s series A adds $20M for cytokine fusion, antibody pipeline

    Cancer
More in Financings
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Science

  • Aging illustration

    Multiple aging hallmarks show up as epigenetic changes

    Age is the biggest risk factor for just about every common disease in high-income countries, which suggests that slowing down cellular aging would have massive effects on individual and public health. Delaying the average onset of Alzheimer’s disease by five years, for example, would roughly halve...
  • Across body parts, ‘parts list’ gives insights into the lives of a cell

    “People often think about the genome as the blueprint of the organism, but that’s not really correct,” Steven Quake told reporters at a Science press briefing earlier this week. “The genome is more of a parts list, because every cell type uses different parts.” Quake is president of the Chan...
  • Inflammation is key to preventing chronic pain, study finds

    Inflammatory
    More than 10% of Americans suffer from chronic pain, and how to prevent acute pain from turning chronic has been a critical question in pain research. But according to a study published in the May 11, 2022, issue of Science Translational Medicine, that approach has it backwards. In several animal...
  • Taking aim at tumor metabolism, while taming toxicity

    Conferences
  • Innate immune memory underlies inflammatory comorbidities: study

    Immune
  • ECCMID 2022: In antibiotic development, scientific ingenuity meets a dysfunctional marketplace

    Conferences
  • AACR 2022: Understanding cancer’s brain is new microenvironment frontier

    Conferences
More in Science

Newco news

  • Eye wireframe illustration

    Vigeneron carves out space in evolving AAV gene therapy landscape

    Ocular
    Although gene therapy is now “a clinical reality,” it still remains an early stage therapeutic modality. That’s the view of Caroline Man Xu, CEO and co-founder of Vigeneron GmbH, a German gene therapy company that has maintained a low profile while steadily staking out a promising position in gene...
  • Pamela Conley, CEO, Nuvig

    ‘Stable’ door opens for Nuvig as $47M series A backs homeostasis bid

    Immune
    Nuvig Therapeutics Inc. emerged from stealth mode with a $47 million series A round to back efforts to develop drugs that induce immune homeostasis as a way of treating autoimmune diseases without disturbing the system’s normal function.
  • T cells

    Engimmune raises $16.7M in seed round to build better T-cell receptors

    Cancer
    Engimmune Therapeutics AG has raised CHF15.5 million (US$16.7 million) in a seed round, as it prepares to address efficacy and safety shortcomings that currently constrain T-cell receptor and soluble TCR cancer therapies. The Basel, Switzerland-based company’s technology brings together genome...
  • Illustration of cancer cells and immunotherapy treatment

    Former Genentech execs launch new immunotherapy biotech LTZ Therapeutics

    Cancer
    After raising $17 million in seed funding, immunotherapy-focused biotech company, LTZ Therapeutics Inc., is announcing plans for the fledgling company whose acronym stands for “Lift to Zenith.” CEO and co-founder Robert Li told BioWorld that the company’s three-tiered immunotherapy platform will...
  • Vial and syringe with DNA

    Keeping it simple: Kelonia raises a $50M series A

    Cancer
    For Kevin Friedman, the secret to making newly emergent Kelonia Therapeutics Inc. a success is reducing complexity and keeping everything as simple as possible. The Boston-based company just raised $50 million in series A funding to further its development of genetic medicines encompassing a range...
More in Newco news

Regulatory

  • Lilly’s Mounjaro first to win US FDA approval for GLP-1 and GIP dual agonist

  • WTO waiver proposal a surprise to US Congress

  • US FDA rejects UCB psoriasis drug Bimzelx, citing facility inspection issues

  • Riddle me this: How are COVID-19 vaccines like smartphones?

  • US NIH COVID-19 technologies going global

  • FDA user fee legislation passes first hurdle in House of Representatives

  • US lawmakers question budget fulcrum for ARPA-H, NIH

  • US Oversight report sheds light on Emergent GMP issues

  • Patient assistance programs attractive fraud target

  • US FDA to consider lower efficacy for kids’ vaccine

U.S.

  • Hand holding FDA blocks

    US FDA issues draft CMC guidance

    Regulatory
    In a draft guidance released May 9, the U.S. FDA described the benefit-risk principles it uses when conducting quality-related assessments of chemistry, manufacturing and controls (CMC) information submitted as part of a new drug application, biologics license application or supplement.
  • Ignoring the courts, US HHS presses forward on 340B enforcement

    Regulatory
  • Better than nothing: FDA limits use of J&J COVID-19 vaccine

    Regulatory
  • Senators: More light needed on PBM practices

    Regulatory
  • US SEC: Impact of Russian invasion must be disclosed

    Regulatory
More in U.S.
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Europe

  • Vaccine administration

    Second booster dose increases immunity, according to Cov-Boost data

    Clinical
    First results from the U.K. Cov-Boost trial, looking at responses to a fourth dose of an mRNA COVID-19 vaccine, show that antibody levels increase more than after the third dose, confirming the precautionary move to give the most vulnerable a second COVID-19 booster in advance of immune response...
  • Pharma calls for reform to combination therapy funding in UK

    Regulatory
    A lack of funding for combination therapies in the U.K. could hold back investment in the country’s biopharma sector – but there are moves afoot to find ways around the issue, pinned by industry on the way the National Institute for Health and Care Excellence (NICE) assesses the value of drugs.
  • Swiss biotech raises $3.4B investment in 2021

    Financings
    Switzerland’s biotechnology sector maintained its strong investment performance in 2021. The final tally for the year came to CHF3.33 billion (US$3.4 billion), which is almost equivalent to its record-breaking total of CHF3.4 billion for 2020.
  • EC takes big step in digital transformation of EU health care

    Regulatory
  • Turkey disputes WTO findings, US 301 calls out the same bad actors

    Regulatory
  • Biogen withdraws EU Aduhelm filing amid announcement of latest CHMP opinions

    Regulatory
  • Dumped by UK government, Valneva turns to Scotland as regulator approves COVID-19 shot

    Regulatory
More in Europe

Clinical

  • Summer stock: Atara shares await July review of phase II MS trial

    Immune
    As the six-month interim analysis of phase II data for ATA-199 in progressive forms of multiple sclerosis (MS) nears, investors in Atara Biotherapeutics Inc. – not to mention patients – are growing more intrigued by the prospect, an off-the-shelf...
  • BMS makes case for Otezla rival deucravacitinib with long-term psoriasis data

    Dermatologic
    Bristol Myers Squibb Co. has announced long-term data from its closely watched psoriasis pill, deucravacitinib, which it hopes will supplant Amgen Inc.’s blockbuster, Otezla (apremilast), as the main oral therapy for the disease.
  • New CEO Shea to lead Inovio’s shift to COVID-19 vaccine booster strategy

    Coronavirus
    Newly appointed President and CEO Jackie Shea looks to have her work cut out for her, as Inovio Pharmaceuticals Inc. decided to ditch its phase II/III COVID-19 vaccination trial in favor of pursuing a booster strategy with INO-4800. That update,...
  • The trouble with TIGITs: Genentech’s failure sparks worry across class

    Cancer
    A phase III failure for Roche Holding AG unit Genentech Inc.'s anti-TIGIT immunotherapy tiragolumab dragged down the share value of several other class entrants. 
  • Wall Street less Leary of psychedelics as field mushrooms

    Neurology/Psychiatric
    Not long ago, people who touted the prospects of psychedelic drugs might have been accused of hallucinating, but in the U.S. and elsewhere the space has expanded in recent years, as mental health treatments remain “stuck where cancer was 50 years...
  • Oxurion shares fall 40% on phase II miss in DME

    Ocular
    Shares in Oxurion NV dropped 40.3% percent May 9 on news that one of its two clinical-stage assets, THR-687, failed to demonstrate efficacy in a phase II trial in diabetic macular edema (DME). The candidate, a small-molecule pan integrin receptor...
More in Clinical

BioWorld Perspectives

  • Health care and politics illustration

    U.S. politicking threatens public trust in the FDA and CDC

    BioWorld
    The truth that every action has a reaction is being proven again in the public square of the U.S. as the shrill, endless clamor of politicians hoping to...
  • C grade on notebook paper

    When it comes to drug quality, is a ‘C’ acceptable?

    BioWorld
    In releasing its annual report card for drug manufacturing inspections in which the per-country/region grading curve peaked at 77% and bottomed at 68%, the...
  • Capsules in blister packs

    A decade of incentives to promote antibiotic development and still no viable route to commercial success

    BioWorld

    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...
  • U.S. money

    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...
More in BioWorld Perspectives

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