Pharmaceutical Technology

MAY 25, 2023

Celltrion USA has received approval from the US Food and Drug Administration (FDA) for Humira (adalimumab) biosimilar, Yuflyma (adalimumab-aaty) , for multiple indications. Yuflyma represents the company’s fifth biosimilar and second anti-TNF biosimilar to receive US FDA approval.

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pharmaphorum

JANUARY 9, 2023

This Nine for 2023 three-part series will argue that, this year, the future-facing Janus prediction of unprecedented and transformative change is true. However, the pandemic is only one of the often deep-rooted forces that will come together in 2023 to exert transformative pressure on healthcare.

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pharmaphorum

OCTOBER 27, 2022

Santhera has completed a rolling application for its Duchenne muscular dystrophy (DMD) therapy vamorolone in the US, setting up a possible approval and launch in the latter half of 2023. Its lead drug has already claimed fast track and rare paediatric disease designations from the FDA.

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Pharmaceutical Technology

JUNE 7, 2023

Eli Lilly has achieved significant gains in the past quarter, leading to it becoming the most valuable pharmaceutical company in the world, with a market cap of $420bn, surpassing Johnson & Johnson. A decision from the FDA is possible for later this year, with Lilly currently finalizing an application for fast-track approval.

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pharmaphorum

DECEMBER 13, 2022

Amgen has its first direct competition in the KRAS inhibitor class following FDA approval of Mirati’s adagrasib as Krazati for a form of lung cancer. Analysts have suggested, however, that the profile of the two drugs is very similar, leading to questions about how successful Mirati will be differentiating Krazati from its rival.

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Pharmaceutical Technology

JUNE 21, 2023

Ketarx will be marketed under the FDA-approved label of ketamine and in dosages that include 10mg/ml, 50mg/ml and 100mg/ml, with the option to boost the concentration and ready-to-administer applications. Ketamine is currently on the FDA’s drug shortage list. Ketarx will then be commercially launched in the second quarter.

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Legacy MEDSearch

JANUARY 13, 2023

implantation of the HIT Reverse Hip Replacement System (Reverse HRS), under an FDA approved Investigational Device Exemption (IDE). Stephen Zabinski, MD, Director of the Division of Orthopaedic Surgery, Shore Medical Center in Somers Point, New Jersey, performed the first surgery using this exciting new technology on January 10, 2023.

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SEPTEMBER 8, 2023

a Silicon Valley pioneering medical device company specializing in novel cardiothoracic solutions, is pleased to announce a significant milestone following receipt of FDA Investigational Device Exemption (IDE) approval to conduct a staged pivotal clinical trial for its Duett Vascular Graft System in the United States. Aquedeon Medical, Inc.,

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Legacy MEDSearch

APRIL 27, 2023

Food and Drug Administration (FDA) for the company’s SIRA RFA Electrosurgical Device (SIRA). Data supporting the breakthrough device designation will be presented at the 24th Annual Meeting for The American Society of Breast Surgeons in Boston, MA on April 26-30, 2023. For more information, visit Innoblative.com. Are you hiring?

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JUNE 14, 2023

Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Pounce LP (Low Profile) Thrombectomy System. Surmodics, Inc. mm to 6 mm in diameter. About Surmodics, Inc.

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pharmaphorum

SEPTEMBER 21, 2022

The European Commission has followed the lead of the US FDA and approved AstraZeneca’s Tezspire as an add-on maintenance therapy for patients with severe asthma, becoming the first and only biologic that can be used in all patients, and not restricted to those with specific forms of the disease. billion or more.

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Pharmaceutical Technology

MAY 15, 2023

Trial centres were located across France, Germany, and the United Kingdom with results collected during the 2022-2023 RSV season. Nirsevimab is still undergoing regulatory review in the US, with the US Food and Drug Administration (FDA) accepting the Biologics License Application (BLA) for nirsevimab in January 2023.

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JUNE 13, 2023

CorNeat Vision’s EverPatch , a synthetic tissue substitute, has been granted 510(k) clearance by the US Food & Drug Administration (FDA). This recent FDA clearance of our first device for ophthalmic use advances us toward our ultimate goal of promoting human health and equality.” Click HERE to learn more.

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AUGUST 21, 2023

Muratoglu invented the first crosslinked polyethylene, and the first of multiple generations of vitamin E, antioxidant polyethylene for leading orthopaedic companies. “We The first products for Activit-E will launch in the beginning of Q3 2023 for select U.S. Global expansion will begin in 2024. Are you hiring?

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pharmaphorum

OCTOBER 27, 2022

The FDA has accepted for review Seres Therapeutics’ Biologics License Application (BLA) for SER-109, an investigational oral microbiome therapeutic for the prevention of recurrent Clostridium difficile infection (rCDI). If approved, SER-109 would be the first-ever FDA-approved oral microbiome therapeutic. Now at $6.79

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Pharmaceutical Technology

APRIL 12, 2023

Under its terms, Pharming has paid a $10m milestone payment to Novartis for the first commercial sale of Joenja. In March 2023, Joenja secured approval from the US Food and Drug Administration (FDA) to treat the targeted patients. Both genes are important for the body’s development and for the functioning of immune cells.

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APRIL 26, 2023

Food and Drug Administration (FDA). Pulse’s FDA clearance means the company’s SphygmoCor technology can now be expanded to be used in decentralized clinical trials, remote patient monitoring, and for self-monitoring at home. Our clients include both blue-chip companies and innovative startups within the MedTech space.

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Clarivate

JANUARY 23, 2024

The just-published 2023 Factbook indicates an industry that is becoming more nimble and efficient in its R&D over the long haul. forecast peak sales per asset versus the cost of developing an asset or an output measure such as the number of global first world launches). However, their full impact on value remains to be realized.

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APRIL 7, 2023

Food and Drug Administration (FDA) has granted 510(k) clearance to the Axiom PSR System for use with the company’s Kinos Axiom Total Ankle System. The Axiom PSR is entering an initial release in April with full availability in June 2023. restor3d, a research-driven medical device company, announced that the U.S. Are you hiring?

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Pharmaceutical Technology

APRIL 4, 2023

While Scorpion will lead the development of STX-721, Pierre Fabre will handle STX-241. The Boston, Massachusetts-based Scorpion expects to submit an investigational new drug (IND) application for STX-721 to the US Food and Drug Administration (FDA) in mid-2023, with an IND application for STX-241 expected in H1 2024.

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Pharmaceutical Technology

MARCH 24, 2023

Amgen’s (US) Amjevita (adalimumab) is the first Humira biosimilar, launched in February 2023, and seven other FDA-approved biosimilars are expected to arrive on the US market later this year. In addition, two more Humira biosimilars are currently under FDA review and both are anticipated to launch in 2023.

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Pharmaceutical Technology

MAY 16, 2023

The company is also in line to receive an additional $110m in future milestone payments, depending on the Chikungunya vaccine development and sales performance of the two marketed vaccines. Following the completion of the deal, Bavarian Nordic now boasts the only oral vaccine licensed by the U.S.

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pharmaphorum

NOVEMBER 21, 2022

“Investors will have some level of concern that this pricing could lead to insurance hurdles,” said a Reuters report citing SMBC Nikko Securities analyst David Hoang, who had been expecting the drug to cost $70,000 to $80,000 per course.

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Pharmaceutical Technology

MAY 16, 2023

This comes with an upfront cash payment of $375 million, with a potential additional $25 million if Hemgenix net sales reach a certain milestone in 2024, based on a May 15 announcement. Additionally, UniQure was set to get tiered royalties of up to “a low-twenties percentage” of net product sales related to Hemgenix.

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Legacy MEDSearch

DECEMBER 19, 2022

.” Added Ferrera, “We are confident that use of the BossStent® device will provide an on-label solution for symptomatic cerebral venous diseases leading to papilledema, pulsatile tinnitus and IIH. Over time, we believe use of the device will become the standard of care.”

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Pharmaceutical Technology

JANUARY 30, 2023

The FDA approved fewer innovative drugs, New Molecular Entities (NMEs), in 2022 than it did in 2021: only 42 drugs compared to 59 drugs. In 2023, there will be opportunities for a wider range of CMOs that can offer services for less innovative drugs requiring reformulation or biosimilar production. months longer on the treatment.

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pharmaphorum

OCTOBER 6, 2022

On the plus side, the time that tirzepatide will stay under review at the FDA has just got shorter, as the FDA has granted the drug fast-track review that means it should make a decision within six months of the filing being completed. billion in 2025 sales.

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pharmaphorum

JANUARY 9, 2023

Albireo secured approval in the US and Europe for the ileal bile acid transport inhibitor (IBATi) drug in 2021 for the treatment of pruritus (itching) in patients with rare disorder progressive familial intrahepatic cholestasis (PFIC), and has said sales should reach $24 million this year. billion deal.

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pharmaphorum

SEPTEMBER 22, 2022

The company said this morning that US sales growth is its main priority, and that it will be led in the near-term by “high-value” new drugs Kisqali (ribociclib), iptacopan, Pluvicto (lutetium Lu 177 vipivotide tetraxetan), remibrutinib, and Scemblix (asciminib).

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Pharmaceutical Technology

MAY 3, 2023

CBMG will receive $245m in an upfront payment and will also be entitled to potential development, regulatory filing, commercialisation and sales milestones along with tiered royalty payments on net trade sales. The transaction is anticipated to be completed in the second quarter of 2023.

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Pharmaceutical Technology

JANUARY 19, 2023

Antigens such as CD123 and CD33, despite being markers of myeloid cells, are shared with their healthy counterparts, and myeloablation following their depletion often leads to detrimental clinical outcomes. NiCord’s biologics license application is currently being investigated by the FDA with a review date set by May 2023.

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Legacy MEDSearch

FEBRUARY 24, 2023

SENSORA FDA-cleared structural murmur detection helps health systems more accurately and consistently identify valvular heart disease (VHD) in patients during a routine visit with their primary care physician. Left undetected and untreated, it can lead to heart failure, stroke, blood clots, and death.

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pharmaphorum

DECEMBER 16, 2022

The positive opinion for etranacogene dezaparvovec – which was approved as Hemgenix by the FDA last month – raises the prospect of the first one-time therapy in the EU for the bleeding disorder, which affects around 1 in 50,000 of the population, according to the European Haemophilia Network (EUHANET).

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Pharmaceutical Technology

MAY 30, 2023

He added that these problems led the CMO to significantly reduce its FY 2023 predictions, from the previously forecast $4.625bn-$4.875bn in net revenue to $4.25bn–$4.35bn, and adjusted EBITDA from $1.22bn–$1.3bn to $725m–$775m. Tech transfers to non-COVID products in Bloomington should finish in H2 2023. ©GlobalData.

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Contrarian Sales Techniques

DECEMBER 14, 2022

The acquisition activity of large pharmaceutical companies is also a result of the lackluster sales of older drugs, the government's scrutiny of the pricing of drugs, and the emergence of new tech firms such as Google and Apple. This can lead to significant losses for large companies. It has gained 12.0% decline of the medical sector.

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pharmaphorum

AUGUST 31, 2022

The FDA will carry out a speedy review of Sanofi and Sobi’s once-weekly haemophilia A treatment efanesoctocog alfa (BIVV001), with a decision now expected by 28 February next year. An EU filing for efanesoctocog alfa will follow after the results from the ongoing XTEND-Kids paediatric trial, due in 2023.

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European Pharmaceutical Review

FEBRUARY 22, 2023

Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. This trial is anticipated to begin in the second half of 2023. References Urquhart L.

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