The Pharma Data

OCTOBER 29, 2020

30, 2020 (GLOBE NEWSWIRE) — Two dominant regional contract research organizations (CRO), Avance Clinical and Cromos Pharma , with operations in Australia and Central/Eastern Europe, respectively, are successfully collaborating on a scalable clinical solution for biotechs. DUBLIN, Ireland and ADELAIDE, Australia, Oct.

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Agency IQ

OCTOBER 20, 2023

BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions This week, FDA and its grantees briefed stakeholders on the status of research projects funded through the Biosimilar User Fee Act (BSUFA III) Regulatory Science Pilot Program. Developing biosimilars is an extensive and expensive process.

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The Pharma Data

DECEMBER 13, 2020

In May 2020, the FDA notified MacroGenics that it was no longer planning to hold an Oncologic Drugs Advisory Committee (ODAC) meeting, but expected to hit the PDUFA date of December 17. Amgen’s ABP 798, a Biosimilar to Genentech’s Rituxan. That collaboration was to develop and commercialize four oncology antibody biosimilar therapies.

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Agency IQ

JANUARY 19, 2024

Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars. However, this is actually relatively aligned with the number of new active substances seen prior to and during the first year of the pandemic: 39 in 2020 ; 30 in 2019 ; 42 in 2018 and 35 in 2017. for the years 2020 to 2022.

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Vial

MARCH 1, 2024

Growth factors for this market included the growing size of the pharmaceutical industry, the increasing number of clinical trials , substantial funds dedicated to pharma and biotech R&D, and the growing biosimilars and generics market. In 2020, PPD successfully listed on Nasdaq and launched its initial public offering (IPO).

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Drug Discovery World

OCTOBER 20, 2022

According to the International Trade Administration’s market overview, anti-tumour agents brought in the largest sales in 2020 in Japan. Similarly, biosimilars are expected to grow. Overview . What is more noteworthy is that products eligible for Conditional Early Approval are not restricted to orphan drugs. .

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The Pharma Data

JANUARY 24, 2021

Meanwhile, the FDA has also approved the Investigational New Drug (IND) application for a global Phase III trial of Toripalimab in combination with Axitinib versus Pembrolizumab for the first-line treatment of patients with advanced mucosal melanoma (Combination Clinical Trial). and a disease control rate (DCR) of 86.2%

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The Pharma Data

NOVEMBER 17, 2021

At the recent Clinical Trials on Alzheimer’s Disease conference (CTAD), Biogen blazoned new Phase 3 findings that give farther substantiation of aducanumab’s effect on lowering amyloid beta shrine and downstream tau pathology, the two defining pathologies of Alzheimer’s complaint.

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The Pharma Data

APRIL 7, 2022

For lecanemab, our partner Eisai has initiated FDA filing via the accelerated approval pathway and the readout of the Phase 3 confirmatory Clarity AD clinical trial is expected in the fall. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

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The Pharma Data

DECEMBER 13, 2020

Supplemental NDAs of toripalimab for the 3 rd line treatment of recurrent/metastatic nasopharyngeal carcinoma and 2 nd line treatment of metastatic urothelial carcinoma were accepted by the NMPA in April and May 2020 respectively. Both supplemental NDAs received priority review status by the NMPA in July 2020. SHANGHAI, China, Dec.

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The Pharma Data

MARCH 16, 2022

(Nasdaq: BIIB) announced that The Journal of Prevention of Alzheimer’s Disease (JPAD) today published a peer-reviewed manuscript detailing data from the pivotal Phase 3 EMERGE and ENGAGE trials for ADUHELM ® (aducanumab-avwa) 100 mg/mL injection for intravenous use in early Alzheimer’s disease. In June 2021, the U.S.

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FDA Law Blog: Biosimilars

MARCH 29, 2024

In March 2020 , FDA temporarily postponed all foreign and domestic and routine surveillance facility inspections. These are BIMO inspections of hospitals, clinical research organizations (CROs), and other similar facilities where clinical trial work is performed. Inspections went down—way down—during the pandemic.

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Agency IQ

JULY 13, 2023

BY ALEXANDER GAFFNEY, MS, RAC JUL 10, 2023 10:02 AM CDT As of FY2023, the FDA has five user fee programs applicable to its life sciences portfolio: PDUFA (for non-generic prescription drugs and certain biologics), MDUFA (for medical devices), GDUFA (for generics), BsUFA (for biosimilars), and OMUFA (for over-the-counter monograph products).

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The Pharma Data

JULY 29, 2021

Billion The 10% Operational Growth Excluding BNT162b2(1) in Second-Quarter 2021 Builds on the 6% Operational Growth Delivered by the Comparable Business in Second-Quarter 2020 Second-Quarter 2021 Reported Diluted EPS(2) of $0.98, Adjusted Diluted EPS(3) of $1.07 Second-Quarter 2021 Revenues of $19.0 Billion for BNT162b2(1), Reflecting 2.1

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The Pharma Data

APRIL 28, 2022

On April 7, CMS issued a final national coverage determination that limited access to ADUHELM for Medicare beneficiaries to only those enrolled in FDA or National Institutes of Health (NIH) approved clinical trials. For those already on ADUHELM, this meant a potential halt in their treatment plans.

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The Pharma Data

MAY 18, 2021

In line with plans announced with the Austrian government in July 2020, Sandoz confirms that in a first step it will proceed to invest more than €100 million to introduce new manufacturing technology for the production of oral amoxicillin, an active pharmaceutical ingredient (API) for its leading penicillin product. billion.

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The Pharma Data

JUNE 24, 2021

today announced that the first participant has been dosed in TALAPRO-3, a global, randomized, double-blind, placebo-controlled Phase 3 clinical trial. The TALAPRO-3 trial will enroll approximately 550 men with DDR-deficient mCSPC across 285 clinical trial sites in 28 countries. About TALAPRO-3 Trial. About talazoparib.

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market. That did not happen.

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The Pharma Data

AUGUST 3, 2021

billion in comparison to the second quarter of 2020, driven by higher unit demand, partially offset by lower net selling prices. billion in the second quarter of 2020 driven by a difference in the timing of tax payments. Total product sales increased 3% for the second quarter of 2021 versus the second quarter of 2020.

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The Pharma Data

AUGUST 3, 2021

Revenue growth was 12 percent when excluding effects of 2020 COVID-related stocking patterns, revenue from COVID-19 antibodies and recent business development. ” $ in millions, exceptper share data Second Quarter % 2021 2020 Change Revenue $ 6,740.1 $ 5,499.4 on a reported basis and increased to $1.87 on a non-GAAP basis.

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The Pharma Data

FEBRUARY 8, 2021

Q4 2020 sales growth (2) of 4.2% Full-year 2020 performance. In 2020, cost savings of €1,680 million were realized of which approximately 60% were reinvested. We continue to work in parallel on our two COVID-19 vaccine candidates, with clinical trials starting in the coming weeks. and business EPS growth of 9.8%

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The Pharma Data

MAY 2, 2022

We believe the results from the LANDSCAPE and NEST programs, in which zuranolone demonstrated rapid and sustained effects and a well-tolerated safety profile in clinical trials, support zuranolone as a potential novel treatment option for MDD, if approved.

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The Pharma Data

FEBRUARY 1, 2021

This approval expands Biogen’s industry-leading portfolio of MS treatments, which also includes the subcutaneous (SC) administration of Plegridy, and follows the European Commission’s marketing authorization for the IM administration in December 2020. “At Chief Medical Officer at Biogen. Source: Biogen. Posted: February 2021.

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The Pharma Data

MARCH 28, 2022

This Phase 1 study was a randomized, placebo-controlled, dose-escalating trial to evaluate BIIB078 administered intrathecally to adults (n=106) with C9orf72-associated ALS. In 2020, Biogen launched a bold 20-year, $250 million initiative to address the deeply interrelated issues of climate, health, and equity.

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The Pharma Data

OCTOBER 29, 2020

29, 2020– Alexion Pharmaceuticals, Inc. NASDAQ:ALXN) today announced financial results for the third quarter of 2020. Non-GAAP diluted EPS for the third quarter of 2020 was $3.24 , a 16 percent increase versus the third quarter of 2019. ” Third Quarter 2020 Financial Highlights. . in the prior year.

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The Pharma Data

MAY 15, 2023

She serves as a Board member at both NVIDIA Corporation and Northwestern Mutual, both since 2020. Before joining Lufthansa, he served as Group CFO at Barry Callebaut based in Switzerland from 2018 through 2020. Aarti holds a PhD in Applied Statistics from the University of California at Riverside, USA.

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The Pharma Data

FEBRUARY 4, 2021

Q4 2020 sales growth (2) of 4.2% Full-year 2020 performance. In 2020, cost savings of €1,680 million were realized of which approximately 60% were reinvested. We continue to work in parallel on our two COVID-19 vaccine candidates, with clinical trials starting in the coming weeks. and business EPS growth of 9.8%

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The Pharma Data

JANUARY 26, 2021

Reddy’s”) and Global Response Aid FZCO (GRA) today announced the termination of Avigan Trial Study conducted in Kuwait focused on moderate to severe COVID patients in a hospital setting. For the year ended March 31, 2020, the company had global revenues of $21 billion, at an exchange rate of 109 yen to the dollar.

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FDA Law Blog: Biosimilars

APRIL 10, 2023

and United Kingdom demonstrating “significant medical benefits” of MDMA and psilocybin, noting that The New England Journal of Medicine published Phase 2b clinical trial results showing that a small dose of psilocybin caused remission of treatment-resistant depression in about 30% of patients. Mace cited recent research in the U.S.

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The Pharma Data

DECEMBER 27, 2020

28, 2020 13:00 UTC. To Our Shareholders, As we reach the end of an eventful 2020, we are inspired by the many healthcare providers and biopharmaceutical companies that worked to combat the COVID-19 pandemic. CARLSBAD, Calif.–( –( BUSINESS WIRE )– Lineage Cell Therapeutics, Inc.

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The Pharma Data

AUGUST 31, 2020

Basel, Switzerland, September 1, 2020 — Novartis and the African Union (AU) through the Africa Medical Supplies Platform (AMSP) have announced a new collaboration to facilitate the supply of medicines from the Novartis Pandemic Response Portfolio to the AU member states and Caricom countries.

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The Pharma Data

SEPTEMBER 16, 2020

16, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) announced today that data from its oncology pipeline in solid tumors will be presented during the European Society of Medical Oncology (ESMO) Virtual Congress 2020, Sept. 19-21, 2020. 20, 2020 , from 2:25 p.m. – 21, 2020 , from 2:25 p.m. – 20, 2020, at?11:00

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The Pharma Data

FEBRUARY 4, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $1.590 Billion; Global Rinvoq Net Revenues Were $731 Million. 3, 2021 /PRNewswire/ — AbbVie (NYSE: ABBV) announced financial results for the fourth quarter and full year ended December 31, 2020. Percent on a Reported Basis, or 12.5

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Agency IQ

JUNE 2, 2023

6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., FDA issued an interim response in June 2020 that said the petition requires “further review and analysis by agency officials.”

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The Pharma Data

DECEMBER 9, 2020

09, 2020 (GLOBE NEWSWIRE) — Today, Biogen (Nasdaq: BIIB) and Eisai, Co., Results in early stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. CAMBRIDGE, Mass. and TOKYO, Dec.

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DrugBank

AUGUST 9, 2024

Moreover, the probability of success for a drug candidate entering clinical trials is only around 10%, highlighting the substantial risks involved. Shorter exclusivity periods, driven by patent challenges and the introduction of generic or biosimilar competitors, significantly contribute to declining ROI.

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The Pharma Data

OCTOBER 29, 2020

30, 2020 (GLOBE NEWSWIRE) — Biogen (Nasdaq: BIIB) and Eisai, Co., Results in early stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. CAMBRIDGE, Mass. and TOKYO, Oct.

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