Driving Dosage Form Developments
PharmaTech
SEPTEMBER 28, 2023
Dosage forms are being shaped by numerous factors, with patient-centricity continuing to be an important driver of decisions in development.
Dosage Related Topics 
With little FDA oversight, melatonin supplements vary widely in actual dosage, study finds
STAT
APRIL 25, 2023
WASHINGTON — Consumers turning to melatonin gummies to get some help falling asleep might be getting a lot more help than they bargained for, according to a new study published Tuesday in the Journal of the American Medical Association.
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Reshaping Dosage Forms
PharmaTech
MARCH 2, 2024
Advancements in personalized medicine and other innovations are transforming the way dosage forms are viewed.
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STAT+: Lawmaker accuses Amgen of placing profits above patients with dosing for a cancer drug
STAT
MAY 14, 2024
At the time, the Food and Drug Administration required Amgen to run a trial confirming earlier test results, as well as a so-called post-marketing study to examine safety and effectiveness at different dosages, in order to gain full approval. Continue to STAT+ to read the full story…
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STAT+: Oral ketamine tablets effective for treating depression, new study finds
STAT
JUNE 24, 2024
In the Phase 2 trial, the results of which were detailed in Nature Medicine , patients who took extended release ketamine tablets at an 180mg dosage twice weekly showed a “statistically significant and clinically meaningful improvement in depressive symptoms” compared to a placebo. Other dosages saw less of an impact.
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STAT+: Airway disease drug from Insmed succeeds in one of the year’s most anticipated trials
STAT
MAY 28, 2024
The trial, called the ASPEN study, tested two dosages of the drug, and the company said both significantly cut rates of pulmonary exacerbations. The drug, brensocatib, reduced so-called pulmonary exacerbations by roughly 20% versus placebo in patients with bronchiectasis, hitting the trial’s primary endpoint.
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Edible sensor delivers real-time antiretroviral dosage data
European Pharmaceutical Review
NOVEMBER 17, 2022
An innovative ingestible sensor technology tested in an interventional clinical trial provided HIV patients with real-time antiretroviral dosage data , enabling them to better control their infection. The post Edible sensor delivers real-time antiretroviral dosage data appeared first on European Pharmaceutical Review.
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STAT+: Lilly launches Zepbound vials in move that could ease supply constraints
STAT
AUGUST 27, 2024
Dosages of Zepbound pens go up to 10 and 15 mg, but Lilly is only offering low-doses vials for now and will evaluate the possibility of selling high-dose vials later on, Patrik Jonsson, an executive vice president at Lilly, said in an interview. Under the new offering, which is meant for patients paying on their own without insurance, 2.5-mg
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Labetalol batch recalled due to wrong dosage labelling
The Pharmacist
JULY 10, 2023
Pharmacists have been instructed to immediately stop […] The post Labetalol batch recalled due to wrong dosage labelling appeared first on The Pharmacist. But the Medicines Healthcare Products Regulatory Agency (MHRA) said that the actual tablets were 200g strength, consistent with the information on the outside of the box.
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Moderna receives $176 million from BARDA for mRNA influenza vaccines
STAT
JULY 2, 2024
Last year Moderna conducted a Phase 1/2 clinical trial of its candidate mRNA-1018, testing H5 and H7 versions at several dosages in a regimen of two shots separated by three weeks. ” The company has already been working on mRNA-based pandemic vaccines, specifically targeting H5 and H7 avian influenza viruses.
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Drug Digest: Focusing on Solid Dosage Trends and Demand
PharmaTech
DECEMBER 6, 2024
In this exclusive Drug Digest video interview an industry expert discusses key trends impacting solid dosage drug development and manufacturing.
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STAT+: Drugmaker raises the price of an old chemo medicine tenfold amid persistent shortages
STAT
OCTOBER 27, 2022
Over the past week, Areva Pharmaceuticals began marketing vials of fludarabine at a wholesale price of $2,736, a much steeper cost than the $272 charged for the same dosage by Fresenius Kabi and the $109 price tag from Teva Pharmaceuticals, according to data from IBM Micromedex, which gathers pricing data that is reported by manufacturers.
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Key senators make a big pivot on bipartisan insulin cost proposal
STAT
APRIL 21, 2023
and Susan Collins (R-Maine) would cap insured patients’ insulin costs at $35 per month for at least one insulin of each type and dosage form, and require pharmacy benefit managers to pass through rebates they collect from insulin manufacturers to the insurance plans that employ them. Jeanne Shaheen (D-N.H.) Read the rest…
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Drug Solutions Podcast: Dosage Forms: Roundtable on Oral Solid Dosage Trends
PharmaTech
OCTOBER 30, 2024
In this podcast episode, we discuss trends in dosage forms, specifically oral solid dosage, as viewed by five industry experts who recently exhibited at CPHI Milan.
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STAT+: More hospital pharmacists are rationing drugs due to increasing shortages
STAT
AUGUST 11, 2023
Specifically, 99% of hospitals pharmacists reported shortages, which is causing 85% to ration treatments and 84% to rely on different dosages.
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L-Theanine Benefits, Usage, Dosage, Side Effects, and More
Welltopia Pharmacy
DECEMBER 11, 2023
What is L-Theanine? L-Theanine is a non-protein amino acid and it’s the main component of Green/Black tea, providing tea’s unique
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EC approves TECVAYLI’s reduced dosage frequency for multiple myeloma
Pharmaceutical Technology
AUGUST 21, 2023
The EC approved Janssen's Type II variation application for reduced dosing frequency of bispecific antibody TECVAYLI for multiple myeloma.
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STAT+: Pharmalittle: We’re reading about fake studies, AbbVie investing in psychedelics, and more
STAT
MAY 15, 2024
At the time, the Food and Drug Administration required Amgen to run a trial confirming earlier test results, as well as a so-called post-marketing study to examine safety and effectiveness at different dosages, in order to gain full approval. Continue to STAT+ to read the full story…
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CPHI Milan 2024: Trends in Oral Solid Dosage Forms
PharmaTech
OCTOBER 7, 2024
Pharmaceutical Technology Europe sat down with Uwe Hanenberg, Head of Product Implementation at Recipharm, to talk about key trends shaping the oral solid dosage market, including technology advances and industry investments.
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Using Tolerance Intervals for Evaluation of Uniformity of Dosage Units Data in Routine Batch Release
PharmaTech
JANUARY 31, 2024
This article introduces that the basic technique for tolerance interval is implemented using the conventional range 85–115% LC where the proposed range in the PF is not taken into account.
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STAT+: Pharmalittle: We’re reading about a Merck deal, weight loss drugs, and lots more
STAT
MAY 29, 2024
Nearly one-third halted treatment within four weeks, before recommended dosages reached the targeted strength. The insurer analyzed pharmacy and medical claims of nearly 170,000 people between July 2014 and December 2023 and found 58% did not complete a 12-week course of the medicines.
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STAT+: Pharmalittle: FDA adds Lilly diabetes drugs to shortage list; WTO delays decision on extending Covid IP waiver
STAT
DECEMBER 19, 2022
The additions come as Lilly last week flagged challenges to meet demand for the two drugs, especially as it makes six dosage forms of Mounjaro and four of Trulicity. The Trulicity, another diabetes treatment in the company’s stable and its biggest-selling drug, was also added to the FDA shortage list.
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Biocon acquires manufacturing facility of Eywa Pharma
Express Pharma
SEPTEMBER 3, 2023
Biocon recently announced that its step-down, wholly-owned subsidiary, Biocon Generics has acquired Eywa Pharma’s oral solid dosage manufacturing facility, located in Cranbury, New Jersey, US, effective September 1, 2023. A company statement informed, “The facility is acquired for a total consideration of $7.7
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STAT+: Pharmalittle: Drugmaker raises price of old chemo med 10-fold amid shortages; Alnylam cites drug-price law in halting trial
STAT
OCTOBER 28, 2022
Over the past week, Areva Pharmaceuticals began marketing vials of fludarabine at a wholesale price of $2,736, much more than the $272 charged for the same dosage by Fresenius Kabi and the $109 price from Teva Pharmaceuticals.
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STAT+: Pharmalittle: Novo faces patent challenge on Wegovy and Ozempic; Senate panel moves to address drug shortages
STAT
OCTOBER 5, 2023
PTO’s Patent Trial and Appeal Board said that Mylan had shown a reasonable likelihood that the Novo patent covering dosage regimes for the drugs was invalid. The U.S.
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Development Process for Transforming a Liquid Protein Solution into a Solid Oral Dosage Form
PharmaTech
DECEMBER 19, 2024
A case study in converting a solution formulation of a protein into an oral solid dosage form utilizing a fluid bed granulation process and some of the complexities involved.
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STAT+: Pharmalittle: Pfizer and Novo disclose upbeat data on oral weight loss drugs; PBM trade group blasts House committee over hearing
STAT
MAY 23, 2023
The study results also suggest the Pfizer medicine may be as effective for weight loss as Ozempic, although there are stark differences in dosage levels. Meanwhile, an oral drug from Pfizer causes a similar amount of weight loss as Ozempic, according to results from a Phase 2 clinical trial, CNBC says. Walgreens asked a U.S.
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DKSH signs distribution pact with Lactalis in Asia and Europe
Express Pharma
MARCH 3, 2024
DKSH’s Business Unit Performance Materials will provide business development, marketing, sales, logistics, and distribution services for Lactalis’ pharma grade lactose for customers producing Finished Dosage Forms (FDFs), including tablets, pills, capsules, liquid solutions, among others in these key markets.
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Collaboration to produce 3D screen printed pharmaceuticals
European Pharmaceutical Review
MARCH 22, 2023
The technology is an additive manufacturing process which enables the development and production of complex formulations and geometrical structures of oral dosage forms to optimise the release profiles of common pharmaceuticals in addition to new drug developments.
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Blister material as a source of nitrosamine impurities
European Pharmaceutical Review
AUGUST 25, 2022
The investigation was launched after NDMA and NDEA were detected in a finished dosage form, though neither were identified in the bulk drug product. With blister packaging among the most commonly used packaging type for pharmaceutical products worldwide, the findings could have significant implications for industry.
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Episode 864: Why Did ISMP Remove the Do Not Crush List from Their Website?
Pharmacy Joe
OCTOBER 25, 2023
Subscribe on iTunes , Android , or Stitcher If you navigate to the page on the website for the Institute for Safe Medication Practices that once hosted the document titled “Oral Dosage Forms That Should Not Be Crushed” you will instead find a notice that the list has been removed from the ISMP website.
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BDR Pharma launches BDENZA oral solution for prostate cancer
Express Pharma
JANUARY 2, 2024
The company informed that the formulation offers lesser side effects in comparison to existing oral dosage forms of Enzalutamide. Unlike fixed-dose tablets, doctors can adjust the dosage to fit each patient better. BDR Pharmaceuticals has introduced BDENZA, an oral solution in 32mg/mL for the management of prostate cancer.
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FDA Approves First Drug to Treat Agitation Symptoms Associated with Dementia due to Alzheimer’s Disease
LifeProNow
MAY 17, 2023
The recommended starting dosage for the treatment of agitation associated with dementia due to Alzheimer’s disease is 0.5 Patients should increase the dosage on days 8 through 14 to 1 mg once daily, and on day 15 to 2 mg once daily. mg taken once daily on days 1 to 7. The recommended target dose is 2 mg once daily.
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Which pharmaceutical companies have the most implant dosed drugs?
Drug Patent Watch
DECEMBER 5, 2023
For a different perspective, see the most popular dosage types. This chart shows the pharmaceutical companies with the most implant dosed drugs. The companies with the most implant dosed drugs… The post Which pharmaceutical companies have the most implant dosed drugs? appeared first on DrugPatentWatch - Make Better Decisions.
Clinical trials authorised for 3D-printed ulcerative colitis drug
European Pharmaceutical Review
NOVEMBER 22, 2022
Radio-imaging agents embedded in specific components of the dosage form were added in early development of the formulation to assess and confirm the location of drug release in the GI tract. According to Triastek, the radio-imaging agents help protect the tablets from dissolving in the stomach.
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Scrub-a-Dub-Dub: FTC is Cleansing the Orange Book of Device Patents
FDA Law Blog: Biosimilars
JUNE 13, 2024
While the relevant regulation defines “drug product” as the “finished dosage form,” which theoretically includes the delivery device, the Court again falls back on the wording in 21 C.F.R. The Court addressed Teva’s valid argument that the Inhaler Patents are drug product patents and thus listable.
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Adare, Laxxon to Collaborate on 3D-Printed Oral Dosage Forms
PharmaTech
SEPTEMBER 20, 2024
The announcement of the pairing comes several months after Adare Pharma Solutions said it would upgrade several of its facilities, including in Milan, Italy, where the 3D printing operations will be located.
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Which pharmaceutical companies have the most suppository dosed drugs?
Drug Patent Watch
NOVEMBER 14, 2022
For a different perspective, see the most popular dosage types. This chart shows the pharmaceutical companies with the most suppository dosed drugs. The companies with the most suppository dosed drugs…. The post Which pharmaceutical companies have the most suppository dosed drugs? appeared first on DrugPatentWatch - Make Better Decisions.
Which pharmaceutical companies have the most spray dosed drugs?
Drug Patent Watch
APRIL 28, 2023
For a different perspective, see the most popular dosage types. This chart shows the pharmaceutical companies with the most spray dosed drugs. The companies with the most spray dosed drugs… The post Which pharmaceutical companies have the most spray dosed drugs? appeared first on DrugPatentWatch - Make Better Decisions.
Emcure Pharma launches 750 mg injectable variant of Ferric Carboxymaltose
Express Pharma
MAY 15, 2023
The new dosage variant is designed to provide a more effective and convenient option for patients with iron deficiency and iron deficiency anaemia (IDA). It is already available in dosage forms 1000mg/ 20ml and 500mg/ 10ml single-use vials. It is already available in dosage forms 1000mg/ 20ml and 500mg/ 10ml single-use vials.
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Which pharmaceutical companies have the most syrup dosed drugs?
Drug Patent Watch
APRIL 22, 2023
For a different perspective, see the most popular dosage types. This chart shows the pharmaceutical companies with the most syrup dosed drugs. The companies with the most syrup dosed drugs… The post Which pharmaceutical companies have the most syrup dosed drugs? appeared first on DrugPatentWatch - Make Better Decisions.
Zydus, Daewoong sign licensing pact to develop, market Leuprolide long-acting injectable in US
Express Pharma
DECEMBER 11, 2023
Zydus Worldwide DMCC, a wholly owned subsidiary of Zydus Lifesciences and Daewoong Pharmaceutical Co announced that they have entered into an exclusive licensing agreement to co-develop and commercialise Leuprolide Acetate for Depot Suspension (RLD: Lupron Depot, AbbVie) in six dosage strengths for the United States (US) market.
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FDA Approves Increased Dosage of Biofrontera’s Ameluz Topical Gel for Actinic Keratosis
PharmExec
OCTOBER 7, 2024
Approval was based on results from Phase I clinical safety studies, which demonstrated that using three tubes of Ameluz maintained similar safety and systemic exposure levels as one tube in treating actinic keratosis in patients undergoing photodynamic therapy.
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Adragos Pharma - poised to make a lasting impact in the pharmaceutical industry
Outsourcing Pharma
APRIL 11, 2024
It concentrates on small molecule dosage forms including sterile and non-sterile liquids, solids, and semi-solids products. Adragos Pharma is a contract development and manufacturing organization (CDMO) that provides development and manufacturing services for drug products.
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