Russian President Vladimir Putin said on Thursday that he and Turkish counterpart Recep Tayyip Erdogan have agreed to deepen their economic, trade and agricultural cooperation.
Putin was speaking at a ceremony to mark the delivery of nuclear fuel to Turkey's first nuclear power plant, which is being built by Russia.
He said the two countries were working on an initiative by Erdogan to send flour made from Russian grain to countries that needed it.
GSK managed to beat analysts’ revenue predictions for the first quarter of the year, despite an 8% decline in turnover pegged back by declines in COVID-19-related products.
The group posted £6.95 billion ($8.6 billion) in revenue – ahead of a £6.5 billion consensus forecast – but stripping out COVID sales of £1.3 billion transformed that into a 10% increase, driven once again by its shingles vaccine Shingrix and HIV therapies sold under the ViiV Healthcare joint venture.
Shingrix grew 19% to £833 million in the quarter, backed up by solid performances for meningitis vaccines Bexsero and Menveo, which rose 34% to £218 million and 40% to £59 million, respectively.
HIV sales were up 24% to just under £1.5 billion, with the growth coming mainly from oral two-drug therapies Dovato (dolutegravir/lamivudine) and Juluca (dolutegravir/rilpivirine), as well as long-acting drugs Cabenuva (cabotegravir/rilpivirine) and Apretude (cabotegravir).
For the full-year, GSK is now pitching at sales growth of 6% to 8% at constant currencies, but the solid performance doesn’t cover up looming concerns about the upcoming expiry in 2027 of patent protection for dolutegravir, potential competition for Shingrix from the likes of Pfizer/BioNTech and Curevo, and an uncertain outlook for a new respiratory syncytial virus (RSV) vaccine currently under regulatory review.
GSK looks like it will be in a strong position with its Arexvy RSV shot, despite challenges from Pfizer and Moderna, having received a strong endorsement from an FDA advisory committee last month. The FDA is due to decide on both GSK and Pfizer jabs in May, while Moderna is preparing to file for approval this quarter.
Despite the RSV programme, the company recognises the need to bolster its pipeline after a series of setbacks for its oncology business, including the withdrawal of multiple myeloma therapy Blenrep (belantamab mafodotin) from the US market.
It has announced a string of acquisitions, most recently a $2 billion bid for Canadian respiratory disease specialist Bellus Health, but also the takeovers of vaccines company Affinivax and Sierra Oncology last year for $3.3 billion and $1.9 billion, respectively.
“We are very focused on our upcoming launches, including our potential RSV older adult vaccine, and on continuing to strengthen our pipeline – both organically, with several positive late-stage read-outs already this year, and through targeted business development,” said GSK's chief executive, Emma Walmsley.
“This continued momentum is also supporting our confidence in delivering our medium and long-term growth ambitions,” she added.
https://pharmaphorum.com/news/shingrix-helps-gsk-make-solid-start-2023
For Biogen, Tuesday’s FDA accelerated approval of Qalsody (tofersen) is a boon for a company in the midst of a redesign, but for superoxide dismutase 1 (SOD1) ALS patients like Todd Legg, it’s an important milestone in advancing gene-specific research for this uniformly fatal disease.
Legg, who was diagnosed with SOD1-ALS in August 2020, entered Qalsody’s Phase III VALOR trial in October of the same year and the open-label extension study in April 2021. As VALOR was blinded, Legg doesn’t know if he was on the drug from the beginning, but his experience leads him to believe that is the case.
“The first few months of the trial, I was still declining very quickly, and then around month four, things started stabilizing a little bit and kept stabilizing more and more,” he told BioSpace. “I don’t want to say that it’s flat now and there’s no decline, but it’s way, way better than it was [at the beginning of the trial],” Legg said he specifically has seen improvement in his muscle strength and breathing.
Qalsody is the first approved therapy for a genetic form of ALS. And beyond SOD1, Legg said the FDA’s decision could encourage more investment into other genetic causes of ALS, as well as the sporadic form of the disease.
Approximately two in three people with familial ALS—and 1 in 10 with sporadic ALS—have a mutation in at least one of the more than 40 genes linked to the disease, according to the ALS Association. These genes include SOD1, C9orf72, TARDBP and FUS.
For Jean Swidler, chair of Genetic ALS & FTD: End the Legacy, having a therapy that is proven to modify the disease process of SOD1-ALS “is a big deal” because it could lead to other drugs and interventions that can modify the biology of ALS in a measurable way.
Swidler’s organization is made up of and supports asymptomatic genetic carriers of ALS and frontotemporal dementia (FTD) as well as people at risk of inheriting genetic mutations that cause these diseases.
“There’s rationale for using [Qalsody in people with SOD1 mutations] before there are clinical symptoms that would normally be associated with the disease, so that’s super exciting for our community,” she told BioSpace.
Indeed, Biogen is now testing the therapy in 150 presymptomatic individuals with a SOD1 mutation and elevated neurofilament light chain (NfL), the biomarker on which Qalsody’s accelerated approval was based. The trial, which will serve as the confirmatory trial to keep Qalsody on the market, is more than half enrolled, a Biogen spokesperson told BioSpace in an e-mail.
Next Steps
Qalsody has not yet been assigned a price, but the Biogen spokesperson said it “will be priced within a range comparable to other recently launched ALS treatments. [Biogen] believe[s] this strikes the right balance between the scientific and clinical innovation [the drug] delivers with the need to get this treatment to patients as quickly as possible.”
Amylyx’s Relyvrio, approved in September 2022 for the treatment of sporadic ALS, for example, carries a price tag of $158,000 per year.
Qalsody will be available for shipment to U.S. healthcare providers in approximately one week, according to Biogen.
Meanwhile, some in the space are hopeful that more ALS treatments are not far behind. That Qalsody’s approval was based on NfL establishes a pathway for other ALS therapies being evaluated based on biomarkers. One of these companies is Cambridge, Mass.-based QurAlis, which targets stathmin-2, a protein involved in neural repair and axonal stability that is downregulated in nearly all people with ALS.
In a March interview with BioSpace, QurAlis CEO Kasper Roet highlighted the importance of the advisory committee meeting for Qalsody, and said he is excited to see biomarkers move to a more mature space in ALS.
Legg relayed the words of his doctor, who told him, “This is first generation. It only gets better from here.”
TG Therapeutics, Inc. (NASDAQ: TGTX) today announced that the U.S. Centers for Medicare & Medicaid Services (CMS) has issued a permanent J-Code for BRIUMVI (ublituximab-xiiy), for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS). Under the Healthcare Common Procedure Coding System (HCPCS), the BRIUMVI J-Code (J2329) will become effective July 1, 2023.
Michael S. Weiss, the Company's Chairman and Chief Executive Officer, stated, “The issuance of a permanent J-Code for BRIUMVI is a significant milestone in our early launch phase. Once in effect, the permanent J-Code will provide a streamlined and efficient reimbursement process, which we believe will facilitate additional patient access. We are encouraged by the early launch of BRIUMVI and look forward to sharing additional details on our first quarter earnings call.”
J-codes are permanent, product specific, reimbursement codes used by commercial insurance plans and government payers for Medicare Part B drugs like BRIUMVI that are administered by a physician. A permanent J-code simplifies the claims submission and documentation process, which in turn streamlines the billing and reimbursement process. The permanent J-code for BRIUMVI is published online on the CMS website here.
PROCEPT® BioRobotics Corporation (Nasdaq: PRCT) (the “Company”), a surgical robotics company focused on advancing patient care by developing transformative solutions in urology, today reported unaudited financial results for the quarter ended March 31, 2023.
Recent Highlights
Total revenue of $24.4 million for the first quarter of 2023, an increase of 72% compared to the prior year period in 2022
U.S. handpiece and consumables revenue of $11.8 million for the first quarter of 2023, an increase of 165% compared to the prior year period in 2022
U.S. system and rental revenue of $8.8 million for the first quarter of 2023, an increase of 13% compared to the prior year period in 2022
Increased fiscal year 2023 total revenue guidance to $128.0 million
Received positive coverage policy decision from United Healthcare, effective June 1, 2023
Signed national sales contract with largest U.S. IDN on April 1, 2023
Intravitreal 4D-150 was well-tolerated with no inflammation in 14 of 15 patients and only trace mixed cells at a single timepoint in one patient; no dose-limiting toxicities, treatment-related serious adverse events (SAE) or hypotony reported across all three dose cohorts with follow-up of 24 – 64 weeks
Dose response demonstrated in favor of high dose 3E10 vg/eye, including superior reduction in supplemental anti-VEGF injections and mean central subfield thickness (CST) reduction
80% of patients in the 3E10 vg/eye high dose cohort did not require supplemental anti-VEGF injections through 36 weeks following a single intravitreal dose of 4D-150
Clinically-meaningful improvement in mean CST of -92 µm at 36 weeks, and stable best corrected visual acuity (BCVA), following a single 3E10 vg/eye intravitreal dose of 4D-150
Phase 2 Dose Expansion stage of PRISM trial (n=50 patients) more than 50% enrolled; enrollment completion expected Q3 this year
Company to host live webcast today at 8:00 a.m. ET with retinal expert Arshad Khanani, M.D., M.A., FASRS
4D Molecular Therapeutics will host a webcast today, Thursday, April 27, 2023 at 8:00 a.m. Eastern Time to discuss clinical data and development plans. Dr. Arshad Khanani will also join today's webcast.
Title: | 4D-150 Phase 1/2 PRISM Interim Clinical Data Webcast and Q&A |
Date/Time: | Thursday, April 27, 2023, 8:00 a.m. ET |
Registration: |
An archived copy of the webcast will be available for up to one year by visiting the “Investors & Media” section of the 4DMT website at https://ir.4dmoleculartherapeutics.com/events.
https://finance.yahoo.com/news/4dmt-presents-positive-interim-data-110000150.html
