Yes we aducanumab? Biogen/Eisai AD bid gains traction, outlook still divided
News from Biogen Inc. and partner Eisai Co. Ltd. that U.S. regulators accepted the BLA related to aducanumab for Alzheimer’s disease (AD) – and assigned it priority review, no less – set Wall Street abuzz, especially as the companies noted in their press release that the FDA “if possible, plans to act early” on the anti-amyloid beta (a-beta) monoclonal antibody. Regulators’ decision came about 30 days after they took receipt of the submission; they could have waited 60.

Yes we aducanumab? Biogen/Eisai AD bid gains traction, outlook still divided
News from Biogen Inc. and partner Eisai Co. Ltd. that U.S. regulators accepted the BLA related to aducanumab for Alzheimer’s disease (AD) – and assigned it priority review, no less – set Wall Street abuzz, especially as the companies noted in their press release that the FDA “if possible, plans to act early” on the anti-amyloid beta (a-beta) monoclonal antibody. Regulators’ decision came about 30 days after they took receipt of the submission; they could have waited 60.
PTC’s risdiplam gets FDA nod as first at-home SMA therapy
More than two weeks ahead of its expected PDUFA date, PTC Therapeutics Inc.’s spinal muscular atrophy (SM) drug, risdiplam, gained FDA approval, making it the first at-home, oral treatment intended for use in adults and children 2 months and older.
Today's news in brief
BioWorld briefs for Aug. 7.
Bayer’s Lampit approved by FDA for treating Chagas disease
Bayer AG’s Lampit (nifurtimox) to treat Chagas disease in pediatric patients, approved by the FDA on Friday, is an oral, antiprotozoal medication for newborns to patients under 18, who weigh at least 2.5 kg and are diagnosed with Chagas disease caused by Trypanosoma cruzi.
Ono teases positive results for Opdivo and bevacizumab combo study
HONG KONG – Osaka, Japan-based Ono Pharmaceutical Co. Ltd. has obtained positive top-line data in its phase III study of a combination of Opdivo (nivolumab, Bristol Myers Squibb Co.) and bevacizumab in lung cancer patients.
Import bans hit Pakistan’s pharma industry
KARACHI, Pakistan – Geopolitics and a fraught relationship with its neighbors are hurting Pakistan’s pharmaceutical industry and the ability of people to access active pharmaceutical ingredients (APIs) and modern drugs.
Bench Press for Aug. 7, 2020
BioWorld looks at translational medicine, including: PRC member affects blood formation during aging; Localized bile acid improves systemic blood glucose control; After injury, astrocytes can make interneurons; In AML, collapse prevents relapse; Starving out Chlamydia.

Analysis and data insight

Best year for biopharma financings in two decades
As the money keeps rolling in, 2020 is certainly a year for the biopharma record books. With a total of $81.26 billion raised through Aug. 6, it is a standout year in every type of financing, hitting all kinds of record highs.
Money raised by biopharma: 2020 vs. 2019
Total raised in public, private and other financings of biopharma companies, comparing 2020 vs. 2019.
Biopharma money raised: Jan. 1-Aug. 6, 2020
Year-to-date money raised in public, private and other financings of biopharma companies.
Biopharma money raised by quarter in 2020 (US$M)
Biopharma money raised to-date and by quarter in 2020, including public, private and other financings.

Financings

Pandemic developers account for 40% of 2020’s record financings
Analysis and data insight
Out of 922 biopharma financings so far in 2020, nearly a quarter of them – 211 – were done by companies working on a COVID-19 therapeutic or vaccine. More strikingly, however, the $27.8 billion raised by those pandemic-focused firms represents about 40% of the $71.8 billion total collected through the end of July. That amount is the highest BioWorld has ever tracked.

Science

Study links mitochondrial DNA to abscopal response
Cancer
The abscopal response is an immune-based antitumor response to distant metastases after selective irradiation of the primary tumor.

Data reported from ENCODE phase III
Genomics
Researchers from the Encyclopedia of DNA Elements (ENCODE) consortium reported data from the third phase of the project. Phase III data, which were published in more than a dozen papers in Nature and its sister journals on July 29, 2020, consisted of 6,000 experiments performed on around 1,300...
Alzheimer’s blood test could improve trials, help find treatments
Neurology/Psychiatric
CYBERSPACE – Data presented at the virtual 2020 Alzheimer's Association International Conference (AAIC) and reported in the July 28, 2020, online issue of the Journal of the American Medical Association (JAMA) demonstrated that blood levels of phosphorylated tau-217 (Ptau-217) did as well as...

Newco news

Australia’s Race Oncology resurrects bisantrene following promising phase II AML results
Cancer
PERTH, Australia – Patients with relapsed or refractory acute myeloid leukemia (r/r AML) who have received three or more lines of therapy are often too sick to get much-needed bone marrow transplants and often run out of options. Melbourne-based Race Oncology Ltd. hopes to change those outcomes with a new take on an old drug that slipped through the cracks in the 1980s.
Time sensitive? Allergy overdue for something new, Iggenix bags $10M series A
Immune
Adopting a new strategy in food allergies and others, South San Francisco-based Iggenix Inc. launched with a $10 million series A round to fund work that CEO Bruce Hironaka told BioWorld puts the company “at the front of the wave.” Companies in the allergy space generally “have not taken full advantages of the developments that we’ve seen in the biotech industry over the last 20 or 30 years,” he said.
Starvation safety switch could make cell therapies safer
Cell therapy
By deleting the gene for uridine monophosphate synthetase (UMPS), an enzyme in the pathway for uridine synthesis, researchers have made cells, including embryonic stem cells and T cells, dependent on dietary uridine. The work, which was published in the July 13, 2020, online issue of Nature Biotechnology, adds a new potential way of controlling cell therapies.
G2GBIO seeks further funds after $9.53M series B financing
Diabetes
HONG KONG – Daejeon, South Korea-based biotechnology company G2GBIO Inc. has raised ₩11.4 billion (US$9.53 million) from a series B financing round, with the funds to be used on clinical trials for a sustained-release Alzheimer’s treatment as well as nonclinical trials for diabetes and sustained-release postoperative pain treatments.
After EU withdrawal, catumaxomab ready for phase III trials again under China’s Lintonpharm
Cancer
The first bispecific antibody to win regulatory approval, Removab (catumaxomab) was voluntarily withdrawn due to commercial reasons. Now Chinese biotech Lintonpharm Co. Ltd., of Guangzhou, said it plans to move catumaxomab to a global phase III trial following an IND approval from China’s NMPA, investigating the trifunctional bispecific antibody in patients with peritoneal carcinomatosis, a form of advanced gastric cancer.

U.S.

Trump promises to bring drug supply chain home
Drugs
With the economy and public health on the line, U.S. President Donald Trump thumped his Made in America pulpit again Thursday on a campaign swing through Ohio, in which he vowed to bring the pharmaceutical supply chain home over the next four years.

Europe

‘Shrinking’ Horizon as EU leaders cut R&D funding even as researchers fight pandemic
Research
LONDON – Research and health emerged as the biggest losers following a marathon four days of negotiations by EU leaders on the bloc’s €1.1 trillion (US$1.3 trillion) 2021 - 2027 budget and the formation of a €750 billion (US$872 billion) pandemic recovery fund. Rather than €94.4 billion over the...

CHMP votes through eight new drugs but nixes FDA-approved Gamifant, Elzonris
Cancer
DUBLIN – Although Europe has moved first to approve Blenrep (belantamab mafodotin), Glaxosmithkline plc’s antibody-drug conjugate (ADC) as a fifth-line therapy in relapsed or refractory multiple myeloma, U.S. patients may well be first to gain access to the new drug.
Brexit countdown looming, despite COVID-19 distractions
Coronavirus
LONDON – While the pandemic raged, Brexit was simmering on the back burner, but now as infections wane, the industry is turning its attention back to being ready for the U.K. cutting ties with the EU at the end of December.

Clinical

Levo’s Prader-Willi syndrome phase III misses primary endpoint but secondary endpoints are strong
Rare diseases
While privately held Levo Therapeutics Inc.’s phase III study of LV-101 (intranasal carbetocin) for treating Prader-Willi syndrome (PWS) failed to meet its primary outcome measurements, the company’s CEO told Bioworld the first secondary endpoint showed a statistical significance that raised her hopes the FDA might approve the selective oxytocin-receptor agonist for the indication.
COVID-19 vaccine race growing ‘titer’ as Novavax unveils phase I data
Vaccine
With strong results in hand from the phase I stage of its phase I/II study testing a would-be COVID-19 subunit vaccine, Novavax Inc.’s president of R&D, Gregory Glenn, said “it’s possible we could go down in the dose” as work proceeds and get similar efficacy.
Lilly goes onsite and three I-Spy giants collaborate for COVID-19 studies
Collaboration
Since more than 40% of U.S. coronavirus deaths have links to U.S. long-term care facilities, Eli Lilly and Co. is getting on the road with a clinical trial design that takes researchers directly to outbreaks.
DHODH enzyme makes catalyst grist for Immunic, others in MS-plus
Immune
Novartis AG didn’t say why the FDA has put off action until September – a delay of three months – on the sBLA for multiple sclerosis (MS) prospect Arzerra (ofatumumab, OMB-157), first cleared in October 2009 for chronic lymphocytic leukemia, but the holdup brought renewed attention to the bustling space, and Immunic Inc. – which held its R&D Day on May 27 – is coming on strong.
Cymabay's seladelpar back on track, with pivotal PBC trial ahead
Gastrointestinal
Shares of Cymabay Therapeutics Inc. (NASAQ:CBAY) shot 37% higher on Monday after top-line data showed 78.2% of people with primary biliary cholangitis (PBC) in the company's disrupted phase III test of seladelpar achieved the primary composite outcome after just three months on a 10-mg dose of the drug vs. 12.5% in the trial’s placebo arm.
Olix close to bringing COVID-19 drug candidate to the clinic
RNAi
HONG KONG – Suwon-based Olix Pharmaceuticals Inc. is completing the final preclinical work before starting clinical trials for its as-yet-unnamed COVID-19 drug candidate, developed inside three months using RNA interference (RNAi) technology.

BioWorld Perspectives

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...
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...

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